Cleared Special

K160301 - Platinum dRF Imaging System

K160301 is an FDA 510(k) clearance for Platinum dRF Imaging System, manufactured by Apelem-Dms Group. The device is a Class 2 Radiology device with product code JAA cleared through the Special 510(k) pathway after a 29-day FDA review.

K160301 · Apelem-Dms Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
29d
Days
Class 2
Risk

K160301 is an FDA 510(k) clearance for the Platinum dRF Imaging System. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Apelem-Dms Group (Nimes 30005, FR). The FDA issued a Cleared decision on March 4, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apelem-Dms Group devices

FDA 510(k) Submission Details - K160301

510(k) Number K160301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2016
Decision Date March 04, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

MEDIcept, Inc.
Sharyn Orton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

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