# K182880: Halifax Imaging Kit

- Pathway: 510(k) (Special)
- Applicant: Halifax Biomedical, Inc.
- Decided: Oct 31, 2018 after 16 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K981556 (1998). 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)
- K121345: SR Suite 1.0, Halifax Biomedical, Inc. (2012) Summary page 4.

## Indications for use
This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.

Source page: https://510kreport.com/device/K182880
Methodology: https://510kreport.com/methodology