MIM Software Inc FDA Record
- Latest inspection VAI · Mar 27, 2015
- No warning letters matched by name
MIM Software Inc has 1 FDA recall, 2 inspections, 23 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MIM Software Inc" is on file.
- Latest recall
- Z-3171-2026 · Jul 31, 2026 · filed under Ge Healthcare
- Latest recall under this name
- Z-1267-2025 · Class II · Feb 19, 2025
- Latest inspection
- Mar 27, 2015 · VAI
- Latest 510(k)
- Oct 26, 2026
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 23 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1267-2025 | Class II | MIM software; System, Image Processing, Radiological | Feb 19, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 27, 2015 | Cleveland, OH | Devices | Voluntary Action Indicated (VAI) | 3004363352 |
| Sep 2, 2011 | Cleveland, OH | Devices | Voluntary Action Indicated (VAI) | 3004363352 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004363352 | Cleveland, OH | 2 | Mar 27, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K261763 | MIM KineticID | Oct 26, 2026 |
| K253270 | Contour ProtégéAI+ | Mar 27, 2026 |
| K251883 | MIM LesionID Pro | Dec 11, 2025 |
| K250035 | Contour ProtégéAI+ | Feb 3, 2025 |
| K243012 | MIM Symphony HDR Fusion | Oct 23, 2024 |
| K233620 | MIM - Centiloid Scaling | May 20, 2024 |
| K232862 | MIM Monte Carlo Dosimetry | May 13, 2024 |
| K232514 | MIM Dose Analysis | May 6, 2024 |
| K231765 | Contour ProtégéAI | Nov 8, 2023 |
| K223774 | Contour ProtégéAI | Apr 6, 2023 |
| K223800 | MIM Additional Tracers | Jan 17, 2023 |
| K220256 | MIM-Ablation | Oct 7, 2022 |
| K213976 | Contour ProtégéAI | Feb 3, 2022 |
| K210632 | Contour ProtegeAI | Oct 20, 2021 |
| K193252 | Contour ProtegeAI | Jul 2, 2020 |
| K190379 | MIM on Linux | Mar 19, 2019 |
| K182624 | MIM - MRT Dosimetry | Dec 18, 2018 |
| K180815 | MIM - SPECTRA Quant | Jun 22, 2018 |
| K172218 | MIM Y90 Dosimetry | Nov 21, 2017 |
| K151913 | MIM-Thin Client (mobile) | Apr 25, 2016 |
MIM Software Inc and the FDA: common questions
Has MIM Software Inc received an FDA warning letter?
No FDA warning letter addressed to the name "MIM Software Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has MIM Software Inc received an FDA Form 483?
FDA has not published a Form 483 for "MIM Software Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect MIM Software Inc?
The most recent FDA inspection on file ended Mar 27, 2015 at Cleveland, OH and was classified VAI. FDA has 2 inspections of MIM Software Inc on file.
Has MIM Software Inc had an FDA recall?
Yes. MIM Software Inc has 1 FDA recall on record. The most recent under this name started Feb 19, 2025. A newer recall, dated Jul 31, 2026, is filed under the related name Ge Healthcare.
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