# K121345: SR Suite 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Halifax Biomedical, Inc.
- Decided: Jun 1, 2012 after 28 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: 6 generations back to K981556 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090279: Sedecal, Millennium Plus, Sedecal., Sa. (2009) Summary page 1.

## Most influential descendants
- K182880: Halifax Imaging Kit (2018), 0 descendants of its own

## 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/K121345
Methodology: https://510kreport.com/methodology