# K244010: ExamVue Apex

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: Feb 24, 2025 after 60 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160143: ClearVision ExamVue Flat Panel Detector, Jpi Healthcare, Inc. (2016) Summary page 5.

## Indications for use
The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The ExamVue Apex flat panel x-ray detector system is not indicated for use in mammography.

Source page: https://510kreport.com/device/K244010
Methodology: https://510kreport.com/methodology