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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 the device name listed in this FDA 510(k) record. The listed applicant is Apelem-Dms Group. It received FDA 510(k) clearance on 2021-01-22 under 510(k) 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. The listed applicant is Apelem-Dms Group. The 510(k) number is K203010.

When did Platinum dRF Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Platinum dRF Imaging System?

The FDA 510(k) record lists Apelem-Dms Group as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Apelem-Dms Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160301Platinum dRF Imaging System

Related Devices (Code: JAA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

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

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