Diagnostic X-ray System/PLX5200A— 510(k) K212134

Substantially Equivalent

Nanjing Perlove Medical Equipment Co., Ltd.

FDA 510(k) clearance K212134 for Diagnostic X-ray System/PLX5200A, Substantially Equivalent on 2021-08-25. Applicant: Nanjing Perlove Medical Equipment Co., Ltd..

Clearance details

Applicant: Nanjing Perlove Medical Equipment Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2021-07-08
Decision date: 2021-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.