# K160937: Senolris

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 1, 2016 after 119 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: 9 generations back to K842308 (1984). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143361: Mammo Workstation, GE Healthcare (2015) Summary page 4.

## Indications for use
SenoIris is designed for diagnostic and non-diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images. It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various modalities. Image routing and compression, as well as centralized workflow steering, including double blind reading and integrated in-image reporting, are part of the solution to support the women’s healthcare professionals to enrich existing workflows for breast imaging needs. Various specific and general interfaces exist to synchronize to other external software on the front- and back-end side. The software also provides functions to directly import data from and export them to mobile storage media or onto the local operating system. Contraindications Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless cleared for use in digital mammography. Review monitors used for primary diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported in the SenoIris must fulfill the regulatory requirements. Image quality must conform with applicable quality guidelines. For Diagnose Mode, all modalities must be certified for soft-copy reading

Source page: https://510kreport.com/device/K160937
Methodology: https://510kreport.com/methodology