FDA 510(k) clearance · back to tracker
Diagnostic X-ray System
Nanjing Perlove Medical Equipment Co., Ltd. cleared K243411 on 2025-05-19, decision: substantially equivalent
K-number
K243411
Sponsor
Nanjing Perlove Medical Equipment Co., Ltd.
Device
Diagnostic X-ray System
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-05-19
Product code
OWB
Advisory committee
Radiology
Medical specialty
Radiology
Regulation number
892.1650
Official FDA record
Open K243411on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.