# K060816: Mim 4.0 (Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Mimvista Corp.
- Decided: May 16, 2006 after 50 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954874 (1996). 31 ancestors in all.
350 later devices descend from it; 6 cite it directly.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052379: Mim 3.5 (Circa), Mimvista Corp. (2005) Summary page 1.
- K041022: Neuroq - Pet DP, Syntermed, Inc. (2004) Summary page 1.
- K042863: Scenium, Siemens Molecular Imaging, Ltd. (2004) Summary page 1.
- K010726: Modification to Mirage, Segami Corp., Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K112930: Mobile Mim (2011), 99 descendants of its own

## Recalls of this device
- Apr 23, 2008 · Not classified · Z-1827-2008: 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 follow

## 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. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.

Source page: https://510kreport.com/device/K060816
Methodology: https://510kreport.com/methodology