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FDA 510(k)

Platinum dRF Imaging System

K-Number: K203010 · 2021-01-22

ApplicantApelem-Dms Group
Decision Date2021-01-22
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Platinum dRF Imaging System is a medical device manufactured by Apelem-Dms Group. It received FDA 510(k) clearance on 2021-01-22 under approval number K203010. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Platinum dRF Imaging System?

Platinum dRF Imaging System is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Apelem-Dms Group. The 510(k) number is K203010.

When was Platinum dRF Imaging System approved by the FDA?

Platinum dRF Imaging System received FDA 510(k) clearance on 2021-01-22, under approval number K203010.

What company makes Platinum dRF Imaging System?

Platinum dRF Imaging System is manufactured by Apelem-Dms Group.

What is the FDA product code for Platinum dRF Imaging System?

The FDA product code for Platinum dRF Imaging System is JAA.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Apelem-Dms Group

K160301Platinum dRF Imaging System

Related Devices (Code: JAA)

K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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