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Comfort Cover

by Precision Dynamics Corporation

510(k) K161920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161920 Date15 Jul 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IZH
Device class
Class II
Regulation
21 CFR Part 892.1710
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Comfort Cover is a disposable protective barrier designed to enhance patient comfort and positioning during mammographic imaging. It serves as a soft, flexible cover that reduces pressure points and improves stability for the patient during breast compression, aiding in consistent image quality while minimizing discomfort.

This device is supplied as a single-use, non-sterile item intended for use in radiology settings, specifically within mammographic systems. It is classified as a Class II medical device under FDA regulations (892.1710) and has received a Traditional 510(k) clearance (K161920). Comfort Cover is compatible with various mammographic imaging systems as referenced in the associated predicate devices.

Similar devices

Other devices filed under FDA product code IZH (System, X-Ray, Mammographic).

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