# K160143: ClearVision ExamVue Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare, Inc.
- Decided: Oct 28, 2016 after 281 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: 5 generations back to K981556 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113812: ATAL-8, Atlaim (2012) Summary page 4.
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a, Samsung Mobile Display Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K244010: ExamVue Apex (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K160143
Methodology: https://510kreport.com/methodology