# K243012: MIM – Symphony HDR Fusion

- Pathway: 510(k) (Special)
- Applicant: Mim Software, Inc.
- Decided: Oct 23, 2024 after 26 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: 17 generations back to K954874 (1996). 110 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232862: MIM – Monte Carlo Dosimetry, Mim Software, Inc. (2024) Summary page 6.

## Most influential descendants
- K251883: MIM – LesionID Pro (2025), 0 descendants of its own

## 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, treatment evaluation, and treatment planning. • 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 using 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 a 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.

Source page: https://510kreport.com/device/K243012
Methodology: https://510kreport.com/methodology