Cleared Traditional

UNICATH FAMILY (K942503) - FDA 510(k) Clearance

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

K942503 · Angiographic Devices Corp. · Radiology device
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Jul 1994
Decision
55d
Days
Class 2
Risk

K942503 is an FDA 510(k) clearance for the UNICATH FAMILY. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Angiographic Devices Corp. (Littleton, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Angiographic Devices Corp. devices

Submission Details

510(k) Number K942503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date July 20, 1994
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
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 K942503.
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