Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mim Software, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
249 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | 2026-03-27 | 179 | 0 |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025-12-11 | 174 | 0 |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025-02-03 | 27 | 0 |
| K243012 | MIM – Symphony HDR Fusion | Mim Software, Inc. | 2024-10-23 | 26 | 0 |
| K233620 | MIM - Centiloid Scaling | Mim Software, Inc. | 2024-05-20 | 189 | 0 |
| K232862 | MIM – Monte Carlo Dosimetry | Mim Software, Inc. | 2024-05-13 | 241 | 0 |
| K232514 | MIM – Dose Analysis | Mim Software, Inc. | 2024-05-06 | 262 | 0 |
| K231765 | Contour ProtégéAI | Mim Software, Inc. | 2023-11-08 | 145 | 0 |
| K223774 | Contour ProtégéAI | Mim Software, Inc. | 2023-04-06 | 111 | 0 |
| K223800 | MIM – Additional Tracers | Mim Software, Inc. | 2023-01-17 | 29 | 0 |
| K220256 | MIM-Ablation | Mim Software, Inc. | 2022-10-07 | 249 | 0 |
| K213976 | Contour ProtégéAI | Mim Software, Inc. | 2022-02-03 | 45 | 0 |
| K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021-10-20 | 231 | 0 |
| K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020-07-02 | 220 | 0 |
| K190379 | MIM on Linux | Mim Software, Inc. | 2019-03-19 | 28 | 0 |
| K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018-12-18 | 85 | 0 |
| K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018-06-22 | 85 | 0 |
| K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017-11-21 | 120 | 0 |
| K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016-04-25 | 287 | 0 |
| K112930 | MOBILE MIM | Mim Software, Inc. | 2011-12-02 | 60 | 0 |
| K103576 | MIM 5.2 (BRACHY) | Mim Software, Inc. | 2011-02-18 | 74 | 0 |
| K103785 | MOBILE MIM | Mim Software, Inc. | 2011-02-04 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda