Platinum dRF Imaging System— 510(k) K203010

Substantially Equivalent

Apelem-Dms Group

FDA 510(k) clearance K203010 for Platinum dRF Imaging System, Substantially Equivalent on 2021-01-22. Applicant: Apelem-Dms Group.

Clearance details

Applicant: Apelem-Dms Group
Product code: Code JAA
Advisory panel: Radiology
Date received: 2020-10-01
Decision date: 2021-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Nimes, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.