Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE HealthCareLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list MIM Software with 23 510(k) clearances, 7 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Oct 26, 2026: MIM – KineticID.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 26, 2026 | MIM – KineticIDK261763 · LLZ | 510(k) clearances |
| Mar 27, 2026 | Contour ProtégéAI+K253270 · QKB | 510(k) clearances |
| Mar 27, 2026 | Contour ProtégéAI+K253270 · Radiology | AI-enabled devices |
| Dec 11, 2025 | MIM – LesionID ProK251883 · LLZ | 510(k) clearances |
| Feb 19, 2025 | MIM software; System, Image Processing, RadiologicalClass II · In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maxi | Device recalls |
| Feb 3, 2025 | Contour ProtégéAI+K250035 · QKB | 510(k) clearances |
| Feb 3, 2025 | Contour ProtégéAI+K250035 · Radiology | AI-enabled devices |
| Oct 23, 2024 | MIM – Symphony HDR FusionK243012 · LLZ | 510(k) clearances |
| May 20, 2024 | MIM - Centiloid ScalingK233620 · LLZ | 510(k) clearances |
| May 13, 2024 | MIM – Monte Carlo DosimetryK232862 · LLZ | 510(k) clearances |
| May 6, 2024 | MIM – Dose AnalysisK232514 · LLZ | 510(k) clearances |
| Nov 8, 2023 | Contour ProtégéAIK231765 · Radiology | AI-enabled devices |
| Apr 6, 2023 | Contour ProtégéAIK223774 · Radiology | AI-enabled devices |
| Feb 3, 2022 | Contour ProtégéAIK213976 · Radiology | AI-enabled devices |
| Oct 20, 2021 | Contour ProtegeAIK210632 · Radiology | AI-enabled devices |
| Jul 2, 2020 | Contour ProtegeAIK193252 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
