# K190311: BIOK7600 Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Biokinemetrics, Inc.
- Decided: Mar 13, 2019 after 29 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: 12 generations back to K981556 (1998). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182551: Wireless Digital Flat Panel Detector, Iray Technology Taicang, Ltd. (2018) Summary page 4.

## Indications for use
The BIOK7600 is intended for use by a qualified doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK7600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only. The BIOK7600 is not intended for mammography.

Source page: https://510kreport.com/device/K190311
Methodology: https://510kreport.com/methodology