# K193317: CoreLite X-Ray Specimen Cabinet

- Pathway: 510(k) (Traditional)
- Applicant: Cirdan Imaging Limited
- Decided: Dec 13, 2019 after 14 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)
- K082432: Core Vision Digital Specimen Radiography (DSR) System, Bioptics, Inc. (2008) Summary page 4.

## Indications for use
The CoreLite device is a cabinet X-ray system used to provide digital X-ray images of specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Performing 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/K193317
Methodology: https://510kreport.com/methodology