Cleared Traditional

COLLIMASTER-90

K911127 · Varian Assoc., Inc. · Radiology
Sep 1991
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K911127 is an FDA 510(k) clearance for the COLLIMASTER-90, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Varian Assoc., Inc. (San Carlos, US). The FDA issued a Cleared decision on September 19, 1991, 189 days after receiving the submission on March 14, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K911127 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1991
Decision Date September 19, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZW — Collimator, Automatic, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610