MIM Software Inc
Cleveland, OH, US
MIM SOFTWARE INC. appears in FDA device records in Cleveland, OH. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to MIM Software Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mimvista Corp.510(k), recall
510(k) clearance history
FDA records hold 26 510(k) clearances for MIM Software Inc between 2005 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2011 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253270 | Contour ProtégéAI+ | QKB | Substantially Equivalent | |
| K251883 | MIM – LesionID Pro | LLZ | Substantially Equivalent | |
| K250035 | Contour ProtégéAI+ | QKB | Substantially Equivalent | |
| K243012 | MIM – Symphony HDR Fusion | LLZ | Substantially Equivalent | |
| K233620 | MIM - Centiloid Scaling | LLZ | Substantially Equivalent | |
| K232862 | MIM – Monte Carlo Dosimetry | LLZ | Substantially Equivalent | |
| K232514 | MIM – Dose Analysis | LLZ | Substantially Equivalent | |
| K231765 | Contour ProtégéAI | QKB | Substantially Equivalent | |
| K223774 | Contour ProtégéAI | QKB | Substantially Equivalent | |
| K223800 | MIM – Additional Tracers | LLZ | Substantially Equivalent | |
| K220256 | MIM-Ablation | QTZ | Substantially Equivalent | |
| K213976 | Contour ProtégéAI | QKB | Substantially Equivalent | |
| K210632 | Contour ProtegeAI | QKB | Substantially Equivalent | |
| K193252 | Contour ProtegeAI | QKB | Substantially Equivalent | |
| K190379 | MIM on Linux | LLZ | Substantially Equivalent | |
| K182624 | MIM - MRT Dosimetry | LLZ | Substantially Equivalent | |
| K180815 | MIM - SPECTRA Quant | LLZ | Substantially Equivalent | |
| K172218 | MIM – Y90 Dosimetry | LLZ | Substantially Equivalent | |
| K151913 | MIM-Thin Client (mobile) | LLZ | Substantially Equivalent | |
| K112930 | MOBILE MIM | LLZ | Substantially Equivalent | |
| K103576 | MIM 5.2 (BRACHY) | LLZ | Substantially Equivalent | |
| K103785 | MOBILE MIM | LLZ | Substantially Equivalent | |
| K071964 | MIM 4.1 (SEASTAR) | LLZ | Substantially Equivalent | |
| K062163 | MIMVIEWER | LLZ | Substantially Equivalent | |
| K060816 | MIM 4.0 (NEURO | LLZ | Substantially Equivalent | |
| K052379 | MIM 3.5 (CIRCA) | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004363352 | 3004363352 | MIM SOFTWARE INC. | 25800 Science Park Dr Ste 180, Cleveland, OH 44122 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IYXCamera, Scintillation (Gamma)
- LMBDevice, Digital Image Storage, Radiological
- OUGMedical Device Data System
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation
- QKBRadiological Image Processing Software For Radiation Therapy
- LLZSystem, Image Processing, Radiological
- MUJSystem, Planning, Radiation Therapy Treatment
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1267-2025 | MIM software; System, Image Processing, Radiological | In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result. | Class II | Open, Classified | |
| Z-1827-2008 | MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP. | In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain