Data / Medical devices / United States / Mim Software Inc.
Mim Software Inc.: FDA-registered device maker in Cleveland, OH, United States, 24 510(k) clearances
Mim Software Inc. is registered with the FDA (registration 3004363352) in Cleveland, OH, United States. It lists 8 device types. The FDA files 24 510(k) clearances under its listings, the newest dated March 27, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004363352
- Address
- 25800 Science Park Dr Ste 180, Cleveland, OH, United States, 44122
- Owner or operator
- MIM Software Inc. (9057943)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 27, 2005
- Registered through
- 2027
- Brand names listed
- CPAI+, Contour ProtegeAI, Contour ProtegeAI (2 models), Contour ProtegeAI (3 and 3.1 models), Contour ProtegeAI (4 models), Contour ProtegeAI+, LesionID Pro, MIM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Camera, Scintillation (Gamma) | IYX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2026 | K253270 | Contour ProtégéAI+ | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| December 11, 2025 | K251883 | MIM LesionID Pro | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| February 3, 2025 | K250035 | Contour ProtégéAI+ | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| October 23, 2024 | K243012 | MIM Symphony HDR Fusion | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 20, 2024 | K233620 | MIM - Centiloid Scaling | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 13, 2024 | K232862 | MIM Monte Carlo Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 6, 2024 | K232514 | MIM Dose Analysis | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| November 8, 2023 | K231765 | Contour ProtégéAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| April 6, 2023 | K223774 | Contour ProtégéAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| January 17, 2023 | K223800 | MIM Additional Tracers | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| October 7, 2022 | K220256 | MIM-Ablation | QTZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| February 3, 2022 | K213976 | Contour ProtégéAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| October 20, 2021 | K210632 | Contour ProtegeAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| July 2, 2020 | K193252 | Contour ProtegeAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| March 19, 2019 | K190379 | MIM on Linux | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| December 18, 2018 | K182624 | MIM - MRT Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180815 | MIM - SPECTRA Quant | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| November 21, 2017 | K172218 | MIM Y90 Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| April 25, 2016 | K151913 | MIM-Thin Client (mobile) | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| December 2, 2011 | K112930 | MOBILE MIM | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| February 18, 2011 | K103576 | MIM 5.2 (BRACHY) | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| September 26, 2007 | K071964 | MIM 4.1 (SEASTAR) | LLZ | Substantially Equivalent | Mimvista Corp. | accessdata.fda.gov |
| May 16, 2006 | K060816 | MIM 4.0 (NEURO | LLZ | Substantially Equivalent | Mimvista Corp. | accessdata.fda.gov |
| October 31, 2005 | K052379 | MIM 3.5 (CIRCA) | LLZ | Substantially Equivalent | Mimvista Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 19, 2025 | 96314 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 23, 2008 | 48114 | Not yet classified | Terminated | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of System, Image Processing, Radiological
- All makers of Medical Device Data System
- All makers of Device, Digital Image Storage, Radiological
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated March 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.