Cleared Traditional

K911127 - COLLIMASTER-90

K911127 is the FDA 510(k) clearance for COLLIMASTER-90 by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code IZW) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

K911127 is an FDA 510(k) clearance for the COLLIMASTER-90. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (San Carlos, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 189 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Assoc., Inc. devices

Submission Details

510(k) Number K911127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1991
Decision Date September 19, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 107d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZW Collimator, Automatic, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 Peers - IZW Collimator, Automatic, Radiographic

All 8
Devices cleared under the same product code (IZW) and FDA review panel - the closest regulatory comparables to K911127.
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
K951372 · Philips Medical Systems, Inc. · May 1995
COLLIMATOR F-20
K920725 · Shimadzu Medical Systems · Apr 1992
STEREO COLLIMATOR RF-T SERIES
K920733 · Shimadzu Medical Systems · Apr 1992
ULTRANET-S COLLIMATOR
K894142 · GE Medical Systems · Nov 1989
X-RAY COLLIMATING DEVICES
K810598 · Midmark Corp. · Apr 1981