Cleared Traditional

K911127 - COLLIMASTER-90

K911127 is an FDA 510(k) clearance for COLLIMASTER-90, manufactured by Varian Assoc., Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K911127

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.

IZW Device Classification - Class 2, Special Controls

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 15
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