# K012750: Adc Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Nov 14, 2001 after 90 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: 2 generations back to K904519 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974597: Adc Compact (Agfa Diagnostic Center), Bayer Corp., Agfa Div. (1998) Summary page 1.

## Indications for use
The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.

Source page: https://510kreport.com/device/K012750
Methodology: https://510kreport.com/methodology