Cleared Traditional

VJW2919 PNEUMATIC COMPRESSION UPGRADE

K920938 · Varian Canada, Inc. · Radiology
Jun 1992
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K920938 is an FDA 510(k) clearance for the VJW2919 PNEUMATIC COMPRESSION UPGRADE, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Varian Canada, Inc. (Canada L7g 2j4, CA). The FDA issued a Cleared decision on June 17, 1992, 111 days after receiving the submission on February 27, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K920938 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1992
Decision Date June 17, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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