Cleared Traditional

K940484 - COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM

K940484 is the FDA 510(k) clearance for COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K940484 · Siemens Medical Solutions USA, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
76d
Days
Class 2
Risk

K940484 is an FDA 510(k) clearance for the COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 76 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K940484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1994
Decision Date April 19, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
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 97
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K940484.
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
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664 · Siemens Gammasonics, Inc. · Dec 1993
MULTI-VIEW PROCESSOR (MVP)
K931184 · Adac Laboratories · Nov 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993