# K251883: MIM – LesionID Pro

- Pathway: 510(k) (Traditional)
- Applicant: Mim Software, Inc.
- Decided: Dec 11, 2025 after 174 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K954874 (1996). 126 ancestors in all.
No later device cites it as a predicate yet.
1 of 127 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243012: MIM – Symphony HDR Fusion, Mim Software, Inc. (2024) Summary page 6.
- K211247: Pet Vcar, GE Medical Systems SCS (2021) Summary page 6.

## Indications for use
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET, and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: • Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. • Create, display, and print reports from medical images. • Registration, fusion display, and review of medical images for diagnosis, staging, treatment planning, monitoring treatment response, and treatment evaluation. • Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. • Localization and definition of objects such as tumors and normal tissues in medical images. • Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. • Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. • Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). • Calculating absorbed radiation dose as a result of administering a radionuclide. • Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD. When used for diagnostic purposes, the mobile thin client is not intended to replace a full workstation and should only be used when there is no access to a workstation.

Source page: https://510kreport.com/device/K251883
Methodology: https://510kreport.com/methodology