Platinum dRF Imaging System
K-Number: K160301 · 2016-03-04
ApplicantApelem-Dms Group
Decision Date2016-03-04
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 2016-03-04 under approval number K160301. 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 2016-03-04. It is manufactured by Apelem-Dms Group. The 510(k) number is K160301.
When was Platinum dRF Imaging System approved by the FDA?
Platinum dRF Imaging System received FDA 510(k) clearance on 2016-03-04, under approval number K160301.
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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Official Source
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