Cleared Traditional

CINEMAC QAS (K936002) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936002 · Xre Corp. · Radiology device
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Sep 1994
Decision
268d
Days
Class 2
Risk

K936002 is an FDA 510(k) clearance for the CINEMAC QAS. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Xre Corp. (Littleton, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 268 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Xre Corp. devices

Submission Details

510(k) Number K936002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date September 09, 1994
Days to Decision 268 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 107d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 49
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K936002.
TOP ACOM STATION
K945293 · Siemens Medical Solutions USA, Inc. · Jan 1995
COMPAS
K945483 · General Electric Co. · Dec 1994
GEMNET
K943355 · GE Medical Systems · Nov 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120 · GE Medical Systems · Jul 1994
ANGIOREX CAS-05A
K941177 · Toshiba America Medical Systems, In.C · Jun 1994
LCA ANGIOGRAPHIC IMAGING SYSTEM
K941946 · GE Medical Systems · May 1994