Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diagnostic X-ray System

K-Number: K243411 · 2025-05-19

ApplicantNanjing Perlove Medical Equipment Co., Ltd.
Decision Date2025-05-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Diagnostic X-ray System is a medical device manufactured by Nanjing Perlove Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under approval number K243411. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diagnostic X-ray System?

Diagnostic X-ray System is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Nanjing Perlove Medical Equipment Co., Ltd.. The 510(k) number is K243411.

When was Diagnostic X-ray System approved by the FDA?

Diagnostic X-ray System received FDA 510(k) clearance on 2025-05-19, under approval number K243411.

What company makes Diagnostic X-ray System?

Diagnostic X-ray System is manufactured by Nanjing Perlove Medical Equipment Co., Ltd..

What is the FDA product code for Diagnostic X-ray System?

The FDA product code for Diagnostic X-ray System is OWB.

Related Clinical Trials

NCT07608614 Sleep and Performance RECRUITING NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT04896476 Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Nanjing Perlove Medical Equipment Co., Ltd.

K212134Diagnostic X-ray System/PLX5200A

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑