Mim Software, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Mim Software, Inc.” (first 2011, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. Since 2017 the median was 132 days, against 129 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 287 |
| 2017 | 1 | 120 |
| 2018 | 2 | 85 |
| 2019 | 1 | 28 |
| 2020 | 1 | 220 |
| 2021 | 1 | 231 |
| 2022 | 2 | 147 |
| 2023 | 3 | 111 |
| 2024 | 4 | 215 |
| 2025 | 2 | 100 |
| 2026 | 1 | 179 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mim Software, Inc. took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 14 | 14 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 7 | 7 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 1 | 1 |
Review panels
- Radiology (22)
Most recent Mim Software, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253270 | Contour ProtégéAI+ | QKB | 2026-03-27 | 179 |
| K251883 | MIM LesionID Pro | LLZ | 2025-12-11 | 174 |
| K250035 | Contour ProtégéAI+ | QKB | 2025-02-03 | 27 |
| K243012 | MIM Symphony HDR Fusion | LLZ | 2024-10-23 | 26 |
| K233620 | MIM - Centiloid Scaling | LLZ | 2024-05-20 | 189 |
| K232862 | MIM Monte Carlo Dosimetry | LLZ | 2024-05-13 | 241 |
| K232514 | MIM Dose Analysis | LLZ | 2024-05-06 | 262 |
| K231765 | Contour ProtégéAI | QKB | 2023-11-08 | 145 |
| K223774 | Contour ProtégéAI | QKB | 2023-04-06 | 111 |
| K223800 | MIM Additional Tracers | LLZ | 2023-01-17 | 29 |
12 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-02-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mim Software, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Mim Software, Inc.” (first 2011, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mim Software, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mim Software, Inc. is 116 days. Since 2017: 132 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mim Software, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 14); QKB (Radiological Image Processing Software For Radiation Therapy, 7); QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, 1).
Next steps
- See all 22 Mim Software, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Mim Software, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.