# K180641: Invenia ABUS Viewer

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 4, 2018 after 53 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 K922470 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151075: BR-ABVS Viewer 1.0, Taihao Medical, Inc. (2016) Summary page 4.

## Indications for use
Image Display of Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images for diagnostic and non-diagnostic review purposes. The device will be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K180641
Methodology: https://510kreport.com/methodology