# K113244: Synapse MPR Fusion

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Dec 22, 2011 after 50 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: 10 generations back to K913770 (1991). 107 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101228: Mirada XD, Mirada Medical, Ltd. (2010) Summary page 2.

## Most influential descendants
- K160108: Synapse PACS (2016), 8 descendants of its own
- K190232: Synapse PACS (2019), 3 descendants of its own
- K243647: Synapse PACS (7.5) (2025), 1 descendant of its own
- K173475: Merge PACS (2017), 1 descendant of its own
- K261713: Synapse PACS (7.6.0) (2026), 0 descendants of its own

## Indications for use
Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use.

Source page: https://510kreport.com/device/K113244
Methodology: https://510kreport.com/methodology