Cleared Traditional

K953336 - VRS 3 WALL STAND (FDA 510(k) Clearance)

Aug 1995
Decision
25d
Days
Class 1
Risk

K953336 is an FDA 510(k) clearance for the VRS 3 WALL STAND. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on August 11, 1995, 25 days after receiving the submission on July 17, 1995.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.

Submission Details

510(k) Number K953336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date August 11, 1995
Days to Decision 25 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXY — Holder, Radiographic Cassette, Wall-mounted
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.1880