# K230140: TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

- Pathway: 510(k) (Traditional)
- Applicant: Compai Healthcare (Suzhou) Co.,Ltd
- Decided: Apr 24, 2023 after 96 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: 7 generations back to K021113 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202713: TrueView 100 Pro, Compai Healthcare (Shenzhen) Co.,Ltd (2020) Summary page 5.

## Indications for use
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 procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

Source page: https://510kreport.com/device/K230140
Methodology: https://510kreport.com/methodology