FDA AI-Enabled Device List: 1,614 Devices by Year and Company

FDA's list of AI-enabled medical devices holds 1,614 devices. Decisions on it run from 29 September 1995 to 29 June 2026, and 95% of them are dated 2018 or later. 1,230 (76%) have radiology as the lead review panel. 1,553 (96%) came through 510(k), 40 through De Novo and 21 through PMA.

FDA says the list is not comprehensive, so these are counts of what FDA has listed. The page this copy came from was current as of 4 September 2026, and the data is dated by the newest decision, 29 June 2026. You can search every row in the AI-enabled device search.

Devices by decision year

Source: FDA's list, counted by scripts/analyze-ai-devices.py. Before 2018 the list holds 87 devices. The full table is in the yearly CSV.

2025 is the largest year, 43% above 2024. The 2026 row is the first half and is short for a reason given under limits below: FDA adds a device to the list a few months after the decision.

Specialties

The panel is FDA's lead review panel for the submission. It follows FDA's classification areas, so it says which part of FDA reviewed the device and not which clinic uses it.

Radiology's share peaked near 87% in 2020 and has fallen each year since, to 75% in 2026. The count outside radiology rose from 24 devices in 2022 to 81 in 2025. Cardiovascular led the non-radiology panels in 2022, 2023 and 2025 (14, 21 and 30 devices) and tied neurology in 2024 at 15. Neurology had 19 in 2025.

Pathways

The prefix of the submission number gives the pathway: K for 510(k), DEN for De Novo, P for PMA. The record for each links to FDA's database.

• 510(k): 1,553 devices. Each was cleared by showing substantial equivalence to a predicate. The 510(k) search lists every clearance under a product code.
• De Novo: 40 devices, with 9 in 2024 the most in one year. A De Novo grant creates a classification that later 510(k)s cite. See the De Novo pathway.
• PMA: 21 rows, 4 of them supplements. Two are dated 1995.

Companies

FDA prints the company named on each submission. The same firm often appears under several spellings, and a large group appears under several names.

The first row takes the largest single printed name in each group: "Siemens Medical Solutions USA, Inc.", "GE Medical Systems Ultrasound and Primary Care Diagnostics", "Philips Ultrasound LLC", "Canon Medical Systems Corporation", "Shanghai United Imaging Healthcare Co., Ltd." and "Aidoc Medical, Ltd.". The second merges names that differ only in case, punctuation, a trailing legal suffix such as Inc, Ltd or GmbH, or a "dba" note. The third groups names that start with the same brand word. The rules are in scripts/ai-devices/build.py and company-groups.json.

Counted by what FDA prints, Siemens Medical Solutions USA leads with 56. Merging spelling variants takes it to 74. Grouping every Siemens name gives 96, and GE leads at 109 across 30 printed names.

The grouping follows names and does not follow ownership. A firm that was renamed or acquired stays under each name it used, and a brand that no longer shares a word with its parent stays apart. The ten largest groups hold 28% of the list.

Most companies appear once. After merging spellings there are 604 company names, and 335 of them (55%) have one device. Groups first appearing on the list were 70 in 2023, 73 in 2024 and 88 in 2025. Of the 516 devices decided since January 2025, 151 belong to a group whose first listed device was dated 2025 or later.

Product codes

The list uses 181 product codes, and five cover 49% of the devices: QIH (automated radiological image processing software, 305 devices), LLZ (image processing systems, 161), IYN (pulsed Doppler ultrasonic imaging systems, 124), JAK (CT systems, 103) and LNH (MR imaging systems, 100). Names and regulation numbers come from openFDA's classification database. Regulation 21 CFR 892.2050, which covers QIH, LLZ and QKB, accounts for 527 devices, a third of the list. QAS, triage and notification software under 892.2080, has 86.

The classes are openFDA's current ones for each code. 1,598 devices sit under codes listed as class II, 12 as class III, 3 as class I and 1 as unclassified.

Predetermined change control plans

FDA's list has no PCCP column. Two device names include the words "with PCCP", and that is the sponsor's wording.

A plan can still be found for 510(k)s. When the review covered one, the clearance letter says: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." scripts/ai-devices/pccp-scan.py reads the letter of every listed 510(k) decided since 1 January 2023, which is after FDORA added section 515C of the FD&C Act in December 2022. It read all 949 letters.

69 of the 949 (7%) say the review included a PCCP. Two more letters mention a PCCP only to correct an earlier letter that said so in error, and they are not counted.

The first such letter is dated 21 July 2023. Since the start of 2025 it is 51 of 505 (10%). By panel since 2023, the share is 17% in cardiovascular (13 of 76), 13% in neurology (7 of 52), 26% in anesthesiology (5 of 19) and 6% in radiology (42 of 743). The 69 belong to 45 companies or groups, and no group has more than four.

The regulatory basis is 21 CFR 807.81(b)(1)(ii): a new 510(k) is not required when there is a PCCP 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. A plan changes what must be filed. The change records stay, as the post on design change control under the QMSR sets out.

The count is a floor for 510(k)s, because a letter can be silent about a plan that exists. De Novo and PMA documents were not read, so the list has no count for them.

What the list can and cannot say

• Selection. FDA says it identified devices "primarily based on the use of AI-related terms in the summary descriptions of their marketing authorization document and/or the device's classification". A device with no such wording in its public summary can be missing. FDA also says it will explore ways to tag devices that use foundation models and large language models. The list has no such tag now, so it cannot show how many devices use them.
• Lag. The Internet Archive's copies of FDA's page carry five "Content current as of" dates between July 2025 and September 2026: 10 July 2025, 5 December 2025, 4 March 2026, 16 June 2026 and 4 September 2026. Each update added 73 to 112 devices. The devices added were decided a median of 100 to 127 days before the page date. The newest decision was 41 to 78 days older than the page date each time. The latest quarter or two always looks thin. scripts/ai-devices/cadence.py reproduces these figures.
• Edits. The March 2026 table had 1,451 rows with 21 repeated submission numbers. The April capture had 1,430. The page date did not change.
• Rows. A row is a submission, and a product cleared three times counts three times.
• Meaning. The list says a device was authorized. It does not say it is marketed, or what kind of AI it uses, or whether it learns after release.

Method

The snapshot of FDA's page and CSV was taken on 9 November 2026 and the HTML table matched the CSV row for row. Product code names, regulation numbers and classes were joined from openFDA, last updated 26 October 2026. Every number in this post comes from scripts/analyze-ai-devices.py and can be rerun against the CSV. The list is the starting point for the AI-enabled medical devices entry's account of how FDA regulates these products.

Frequently asked questions

How many AI-enabled medical devices has FDA authorized?

FDA's list holds 1,614, with decisions through 29 June 2026. FDA says the list is not comprehensive.

How many AI devices did FDA authorize in 2025?

335 on the list have a 2025 decision date: 329 through 510(k), 4 through PMA and 2 through De Novo.

What share of AI-enabled devices are in radiology?

76% (1,230 of 1,614) have radiology as the lead panel. The share was 87% in 2020 and 75% for 2026 decisions so far.

Which company has the most AI-enabled devices on FDA's list?

By the name FDA prints, Siemens Medical Solutions USA with 56. Grouping all GE names gives 109, and all Siemens names 96.

Do the devices on the list have predetermined change control plans?

FDA's list does not say. Among the 949 listed 510(k)s decided since 2023, 69 have a clearance letter stating that the review included a PCCP.

Where can I download the data?

FDA offers a CSV on its list page. The CSV for this post adds product code names, merged company names and PCCP flags.