# K100881: Synapse Obliquus Mip/MPR/Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Apr 14, 2010 after 15 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: 3 generations back to K033712 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061672: Synapse Mip/MPR Image Visualization Software Obliquus, Fujifilm Medical Systems U.S.A, Inc. (2006) Summary page 1.
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K124048: Imageqube (2013), 0 descendants of its own

## Indications for use
Synapse Obliquus MIP/MPS/Fusion software enables the display of 3D (MIP/MPR).visualization of CT, MR and PET studies and fusion or blending of CT and PET studies. Typical users are radiologists, technologists, and clinicians. Obliquus is not intended for mammography use.

Source page: https://510kreport.com/device/K100881
Methodology: https://510kreport.com/methodology