Platinum dRF Imaging System— 510(k) K203010

Name: FDA 510(k) clearance K203010
Creator: U.S. Food and Drug Administration
Published: 2021-01-22

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. Device class: 2.

Clearance details

Applicant: Apelem-Dms Group
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
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 ↗

Recent devices under product code JAA

view all

K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
K242488 — Soteria E-View2025-01-06
K242948 — Adora DRFi (04550010)2024-12-23
K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

More clearances from Apelem-Dms Group

view all

K160301 — Platinum dRF Imaging System2016-03-04
K131766 — PLATINUM DRF IMAGING SYSTEM2013-12-12

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.