K243411
- 510(k) number
- K243411
- Device name
- Diagnostic X-ray System
- Applicant
- Nanjing Perlove Medical Equipment Co., Ltd. CN
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-05-19
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243411.pdf
Official FDA record: K243411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.