# K142698: PerkinElmer, XRpad 4343 F MED Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Perkinelmer, Inc.
- Decided: Oct 23, 2014 after 31 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: 8 generations back to K981556 (1998). 15 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140551: Perkinelmer, Xrpad 4336 Med Flat Panel Detector, Perkinelmer, Inc. (2014) Summary page 4.

## Most influential descendants
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own
- K223060: DigiX FDX (2022), 4 descendants of its own
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own

## Indications for use
The XRpad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

Source page: https://510kreport.com/device/K142698
Methodology: https://510kreport.com/methodology