# K213691: Solas OR

- Pathway: 510(k) (Traditional)
- Applicant: Cirdan Imaging, Ltd.
- Decided: Dec 22, 2021 after 29 days
- Product code: MWP (Cabinet, X-Ray System)
- 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: 3 generations back to K021113 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091558: Biovision Digital Specimen Radiography System, Bioptics, Inc. (2009) Summary page 4.

## Indications for use
The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Source page: https://510kreport.com/device/K213691
Methodology: https://510kreport.com/methodology