FDA AI-Enabled Medical Devices

Data through 29 June 2026.

Devices on FDA's list

1,614

Radiology lead panel

1,230 (76%)

510(k) / De Novo / PMA

1,553 / 40 / 21

List page current as of

4 September 2026

Devices by decision year

2026 (to 29 June 2026)135 radiology

181

2025254 radiology

335

2024183 radiology

235

2023178 radiology

226

2022138 radiology

162

2021110 radiology

129

202099 radiology

114

201951 radiology

80

201840 radiology

65

Before 2018

87

Decision dates, as FDA lists them. FDA adds a device only after its public summary is out, so the latest months fill in later.

Lead review panel

Radiology

1,230

Cardiovascular

154

Neurology

73

Anesthesiology

30

Gastroenterology-Urology

27

Hematology

22

Ophthalmic

10

Pathology

10

The panel that reviews the product code, which is not always the specialty that uses the device.

Most common product codes

QIH: Automated Radiological Image Processing SoftwareClass II

305

LLZ: System, Image Processing, RadiologicalClass II

161

IYN: System, Imaging, Pulsed Doppler, UltrasonicClass II

124

JAK: System, X-Ray, Tomography, ComputedClass II

103

LNH: System, Nuclear Magnetic Resonance ImagingClass II

100

QAS: Radiological Computer-Assisted Triage And Notification SoftwareClass II

86

QKB: Radiological Image Processing Software For Radiation TherapyClass II

46

MYN: Analyzer, Medical ImageClass II

43

QFM: Radiological Computer-Assisted Prioritization Software For LesionsClass II

40

QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerClass II

36

Most devices by company, spelling variants merged

Siemens Medical Solutions USA, Inc.

74

Canon Medical Systems Corporation

42

Shanghai United Imaging Healthcare Co., Ltd.

39

Aidoc Medical, Ltd.

35

GE Medical Systems Ultrasound and Primary Care Diagnostics

31

GE Medical Systems, LLC

26

Philips Ultrasound LLC

24

iSchemaView Inc.

19

Samsung Medison Co., Ltd.

18

Siemens Healthcare GmbH

15

Each row is one company name after case, punctuation and suffixes such as Inc and Ltd are ignored. GE, Siemens and Philips appear under several names, so see the guide for the grouped counts.

Source: FDA's list of AI-enabled medical devices, copied by a script. Product code names come from openFDA's device classification database.

FDA's Center for Devices and Radiological Health keeps a list of AI-enabled medical devices authorized for marketing in the United States. This tool holds a copy: 1,614 devices with decisions dated 29 September 1995 to 29 June 2026. Each row is one marketing authorization, a 510(k) clearance, a De Novo grant or a PMA approval, and each links to FDA's own database entry for it.

FDA says the list “is not a comprehensive resource of AI-enabled medical devices”. It includes devices FDA identified “primarily based on the use of AI-related terms in the summary descriptions of their marketing authorization document and/or the device's classification”, with the terms taken from its Digital Health and Artificial Intelligence Glossary. A device that has been authorized but has no published summary yet is added in a later update. The list is therefore a lower bound on what FDA has authorized, and the choice of what counts as AI is FDA's.

There is no separate AI pathway. A device on this list went through the same 510(k), De Novo or PMA route as any other device of its type. The AI-enabled medical devices entry covers how the routes apply to software, and the analysis of the list counts what it holds by year, specialty, company and pathway.

Date of final decision

The date FDA cleared, granted or approved the submission, as FDA prints it. It is the decision date, not the date the device reached the list.

Submission number

The K, DEN or P number. The prefix gives the pathway, and the number links to the record in FDA's 510(k), De Novo or PMA database. PMA supplements carry an /S suffix.

Device

The trade name as the sponsor gave it. Some entries list several models or versions.

Company

The manufacturer named on the submission. This tool merges spelling variants and shows the name FDA prints when it differs.

Lead panel

FDA's lead review panel for the submission, such as Radiology or Cardiovascular. It follows FDA's classification panels and is not the clinical specialty of the person using the device.

Product code and class

FDA's three-letter primary product code. The code's name, regulation number and device class come from openFDA's classification database and show today's classification.

PCCP

Added by this tool for 510(k)s decided since 2023: whether the clearance letter says the review included a predetermined change control plan. FDA's list has no such field.

The search box reads the device name, company name, submission number, product code and the code's name. Every word must match, so a second word narrows the result. A company name, a body part or a submission number all work.

• Pick a year and a pathway to see, for example, the De Novo grants of 2024. Each dropdown shows only the values that still return a device.
• Pick a product code to list every device FDA filed under it, then read the names to find the company's direct competitors.
• Tick the PCCP box to list the 510(k)s whose clearance letter says the review included a plan.

The address bar updates with your filters, so a search can be linked. Results run newest decision first, 25 to a page.

Each of these links to a filtered view you can adjust.

• Product code QAS lists the radiological triage and notification software FDA has filed under one code. A company planning a similar product can read who is already there and when each was cleared.
• De Novo grants dated 2024 shows the devices that had no predicate, which is where new product codes come from.
• Cardiovascular devices with a PCCP lists the cardiovascular 510(k)s whose clearance letter says the review included a change control plan.
• A company name returns every device under that name and, through the group field, the names it shares a brand word with.

The list is a way to find cleared AI devices, and it is not a list of predicates. Whether an earlier device can serve as one turns on intended use and technological characteristics, which the 510(k) summary describes. Open the record, read the summary, and then check the clearance in the 510(k) search.

The prefix of a submission number tells you where the record lives.

• K numbers are 510(k) premarket notifications, in FDA's 510(k) database. 1,553 devices on the list. The 510(k) search reaches the same records and every other clearance in a product code.
• DEN numbers are De Novo requests, in the De Novo database. 40 devices. A De Novo grant creates the classification and the product code that later 510(k)s cite. See the De Novo pathway.
• P numbers are PMAs and their supplements, in the PMA database. 21 devices.

The database record carries the 510(k) summary or statement, the De Novo decision summary, or the PMA summary of safety and effectiveness. Those documents are where a sponsor describes the algorithm, the training and test data, and the performance study, and what they say varies by sponsor. FDA notes the summaries are not all inclusive.

The list uses 181 product codes. Five of them cover about half the devices, and all five sit in radiology. The most common is QIH, automated radiological image processing software, with 305 devices.

A product code is how FDA files a device type. It carries the regulation number and the device class, and the 510(k)s under one code are where a submitter looks for a predicate (see substantial equivalence). Several codes on the list are written for software that reads images, such as triage and notification software and software that flags lesions suspicious for cancer. Others are hardware codes, such as ultrasound and CT systems, which FDA lists when a device's summary uses AI terms.

The class shown is the class of the code in openFDA today, from the device classification database. A code can be reclassified after a device was cleared under it.

A predetermined change control plan (PCCP) is a plan, authorized with the device, for changes the manufacturer intends to make later. Under 21 CFR 807.81(b)(1)(ii), a new 510(k) is not required for a device when a PCCP has been cleared under section 515C of the FD&C Act and the change is consistent with it. FDA's guidance on PCCPs for AI-enabled device software functions was issued on 4 December 2024 and reissued on 18 August 2025 (guidance text). Design change records still apply, as the design change control post explains.

FDA's list does not say which devices have a plan. Two device names include the words “with PCCP”, which is the sponsor's wording.

For 510(k)s the answer is in the clearance letter. When the review covered a plan, the letter says: “FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).” The script scripts/ai-devices/pccp-scan.py reads the letter of every listed 510(k) decided since 1 January 2023. FDORA added section 515C in December 2022. Of the 949 letters read, 69 contain that sentence. Two more mention a PCCP only to correct an earlier letter that said so by mistake, and they are not counted.

The scan does not cover De Novo or PMA documents, and a letter can be silent about a plan that exists. Treat the count as a floor for 510(k)s.

FDA says it updates the list periodically. The Internet Archive holds copies of FDA's page, and the “Content current as of” date on them shows five states between July 2025 and September 2026: 10 July 2025, 5 December 2025, 4 March 2026, 16 June 2026 and 4 September 2026. The gaps are 148, 89, 104 and 80 days. Each update added between 73 and 112 devices. At each one, the newest decision was 41 to 78 days older than the date on the page.

The devices added in an update were decided a median of 100 to 127 days earlier. A device cleared in the last three or four months is usually not on the list yet, so the latest year always looks lower than it will. The page this copy came from was current as of 4 September 2026, and its newest decision is 29 June 2026. The copy was taken 9 November 2026.

scripts/ai-devices/cadence.py reproduces these figures from the archive. In the 8 March 2026 capture the table had 1,451 rows with 21 repeated submission numbers, and the 5 April capture had 1,430. The page date did not change.

• The list is FDA's selection. A device with no AI wording in its public summary can be missing, and the list does not say what kind of AI a device uses or whether it learns after release.
• A row is a submission. A product cleared three times appears three times, and 21 PMA rows include supplements.
• Company names are the ones on the submission. A firm that was renamed or acquired appears under each name it used. This tool merges spelling variants and groups names that begin with the same brand word, such as GE or Siemens. It does not follow ownership, and it does not attach a brand to a different name.
• Lead panel and product code class describe the review and the code, not the clinical use. A device read by a radiology panel can be used in a cardiology clinic.
• Decision dates are FDA's. The list shows when a device was authorized and says nothing about whether it is on the market.
• The PCCP flag comes from one sentence in a clearance letter, for 510(k)s decided since 2023 only.

FDA offers its own list as a CSV, Excel and XML file on its list page. This tool's copy adds the product code names, regulation numbers, device classes, merged company names and the PCCP flag. It is public as a spreadsheet at arca.inc/data/ai-enabled-devices.csv, as JSON at arca.inc/data/ai-enabled-devices.json, and as yearly counts at arca.inc/data/ai-enabled-devices-by-year.csv.

FDA's site blocks automated requests from cloud servers, so the copy is refreshed by a script run on a laptop after FDA updates the page, and the site is rebuilt from the committed file. The scripts and a README are in the scripts/ai-devicesfolder of this site's repository. Counts quoted in the analysis post are dated, and scripts/analyze-ai-devices.py recomputes them.

How many AI-enabled medical devices has FDA authorized?

FDA's list holds 1,614 devices, with decisions dated 29 September 1995 to 29 June 2026. FDA says the list is not comprehensive, so it is a floor and not a census.

Is the FDA list complete?

No. FDA says it is not a comprehensive resource. It includes devices FDA identified mainly from AI-related terms in the summary descriptions of their marketing authorization documents, or from the device's classification. A device whose public summary does not use those terms can be missing, and a device without a published summary cannot be found at all.

How many of the devices are radiology devices?

1,230 of 1,614 (76%) have radiology as the lead review panel. Cardiovascular is next with 154.

How many AI devices were authorized in 2025?

335 devices on the list have a 2025 decision date: 329 510(k)s, 2 De Novo requests and 4 PMAs. The list is still catching up on 2026. Its newest decision is 29 June 2026.

Which pathway do most AI devices use?

The 510(k): 1,553 of 1,614. 40 came through De Novo and 21 through PMA. The prefix of the submission number tells you which: K for 510(k), DEN for De Novo, P for PMA.

Which companies have the most AI-enabled devices on the list?

Counting names as FDA prints them, Siemens Medical Solutions USA, Inc. leads with 74. Merging spelling variants and grouping names that share a brand word, GE has 109 and Siemens 96. The search box takes either spelling.

Does the list say which devices have a predetermined change control plan?

No. FDA's list has no PCCP field. For 510(k)s decided since 2023 this tool read the clearance letter, which says when the review included a PCCP. 69 of the 949 letters read say so. De Novo and PMA documents were not read.

Does the list include devices that use large language models?

FDA's page says it will explore ways to identify and tag devices that incorporate foundation models, from large language models to multimodal architectures, in a future update. The list has no such tag today.

Does FDA's database entry show the AI model?

Sometimes. The entry links to the 510(k) summary, De Novo decision summary or PMA summary, and what it says about the algorithm depends on what the sponsor wrote. FDA notes the summaries are not all inclusive.

How often is the list updated?

FDA says periodically. The page we copied said it was current as of 4 September 2026, and its newest decision was 29 June 2026. This copy was taken 9 November 2026 and is refreshed by hand, so a change FDA made in the last few weeks may not be in it.

Can I download the data?

FDA offers a CSV, Excel and XML file on its list page. This tool's copy is public as a spreadsheet at arca.inc/data/ai-enabled-devices.csv and as JSON at arca.inc/data/ai-enabled-devices.json, with the product code names, merged company names and PCCP flag added.

The most recent decisions on the list, for readers who prefer a page to a search box. Each entry opens FDA's database record.

• 29 June 2026: K260667 Alturion Series Diagnostic Ultrasound System, Philips Ultrasound LLC
• 29 June 2026: K253969 ADAS 3D, Adas3D Medical S.L
• 29 June 2026: K253628 Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012), Agada Medical, Ltd.
• 27 June 2026: K253390 SOMNUM (SOMNUM), Honeynaps Co., Ltd.
• 26 June 2026: K260714 MammoScreen® (5), Therapixel
• 25 June 2026: K253786 syngo.CT Coronary Cockpit, Siemens Medical Solutions USA, Inc.
• 24 June 2026: K253560 Enhanced Boundary for PCCT, GE Medical Systems, LLC
• 22 June 2026: K260316 CMN Capillary Function with Oncology Virtual Expert, Cercare Medical A/S
• 22 June 2026: K253148 RX-1 Sleep, Vivaquant, Inc. Dba Rhythm Express
• 18 June 2026: K261713 Synapse PACS (7.6.0), FUJIFILM Healthcare Americas Corporation
• 18 June 2026: K260729 Vascular Assist Occlusion Triage (VAOT) (v1.0), GuideAI Health
• 18 June 2026: K260190 ARTHUR, ROPCA ApS
• 18 June 2026: K253050 RadOncAI, Informai
• 16 June 2026: K260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…, Siemens Medical Solutions USA, Inc.
• 15 June 2026: K260300 WatchMate Software, Anumana, Inc.
• 15 June 2026: K253825 Saige-Dx, DeepHealth, Inc.
• 15 June 2026: K253690 LungMaps, Siemens Healthineers AG
• 15 June 2026: K253172 MediAI-OA, Crescom Co., Ltd.
• 12 June 2026: K260406 Brainomix 360 Hyperdensity, Brainomix Limited
• 11 June 2026: K260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), Mighty Oak Medical
• 10 June 2026: K253192 DeepXray Spina, Alpha Intelligence Manifolds, Inc.
• 8 June 2026: K260332 EchoNext, Pathwai, Inc.
• 4 June 2026: K261519 Sonio Suspect, Sonio
• 4 June 2026: K260497 DEEPVESSEL Plaque, Keya Medical Technology Co., Ltd.
• 4 June 2026: K253984 Instrument Exit Point on Touch Surgery™ Aide, Covidien, LLC