# K233714: BreView

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Jan 25, 2024 after 66 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: 5 generations back to K871859 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113456: Ready View, Ge Healthcare (Ge Medical Systems Scs) (2012) Summary page 4.

## Indications for use
BreView is a tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and treatment planning.

Source page: https://510kreport.com/device/K233714
Methodology: https://510kreport.com/methodology