# K212134: Diagnostic X-ray System/PLX5200A

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Perlove Medical Equipment Co., Ltd.
- Decided: Aug 25, 2021 after 48 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192011: PhoeniX, Sedecal., Sa. (2019) Summary page 4.
- K201340: Aquila 320 D / Aquila 320 S, Vmi Tecnologias Ltda (2020) Summary page 4.

## Indications for use
The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.

Source page: https://510kreport.com/device/K212134
Methodology: https://510kreport.com/methodology