# K243411: Diagnostic X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Perlove Medical Equipment Co., Ltd.
- Decided: May 19, 2025 after 199 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K042646 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222080: Garion Image-Intensified Fluoroscopic X-Ray System, Mobile, Sg Healthcare Co, Ltd. (2022) Summary page 5.

## Indications for use
The Diagnostic X-ray System is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Source page: https://510kreport.com/device/K243411
Methodology: https://510kreport.com/methodology