Cleared Traditional

K161920 - Comfort Cover

K161920 is an FDA 510(k) clearance for Comfort Cover, manufactured by Precision Dynamics Corporation. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K161920 · Precision Dynamics Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
2d
Days
Class 2
Risk

K161920 is an FDA 510(k) clearance for the Comfort Cover. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Precision Dynamics Corporation (Valencia, US). The FDA issued a Cleared decision on July 15, 2016 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K161920

510(k) Number K161920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2016
Decision Date July 15, 2016
Days to Decision 2 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 107d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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

Third Party Review Group, LLC
DAVE YUNGVIRT

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 - IZH System, X-ray, Mammographic

All 141
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K161920.
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