# K132188: Mammography Viewer SMV658

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Oct 25, 2013 after 102 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: 7 generations back to K842308 (1984). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081630: Mammo Workstation, Image Diagnost International GmbH (2008) Summary page 2.

## Indications for use
ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation. ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.

Source page: https://510kreport.com/device/K132188
Methodology: https://510kreport.com/methodology