# K052379: Mim 3.5 (Circa)

- Pathway: 510(k) (Traditional)
- Applicant: Mimvista Corp.
- Decided: Oct 31, 2005 after 62 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: 5 generations back to K954874 (1996). 19 ancestors in all.
353 later devices descend from it; 4 cite it directly.
1 of 373 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001276: Medical Image Merge (Mim), Syntermed, Inc. (2000) Summary page 2.
- K011572: Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS), Digirad Corp. (2001)
- K001026: 3D-Mspect, The Reagents of the University of Michigan (2000) Summary page 2.
- K040141: Emory Cardiac Toolbox Version 2.6, Syntermed, Inc. (2004) Summary page 2.
- K981535: Focus Pilot Contouring Workstation, Computerized Medical Systems, Inc. (1999). Our reading of the summary gave K981536, FDA’s number for Quantech Myoglobin Assay (Hellen Professional Services). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Focus Pilot software”. Summary page 1.

## Most influential descendants
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own
- K103785: Mobile Mim (2011), 120 descendants of its own

## Indications for use
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as, SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity.

Source page: https://510kreport.com/device/K052379
Methodology: https://510kreport.com/methodology