Cleared Traditional

K934496 - X-RAY ANGIOGRAPHIC SYSTEM

K934496 is an FDA 510(k) clearance for X-RAY ANGIOGRAPHIC SYSTEM, manufactured by Camtronics, Ltd.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K934496 · Camtronics, Ltd. · Radiology device
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Dec 1993
Decision
89d
Days
Class 2
Risk

K934496 is an FDA 510(k) clearance for the X-RAY ANGIOGRAPHIC SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Camtronics, Ltd. (Hartland, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 89 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 Camtronics, Ltd. devices

FDA 510(k) Submission Details - K934496

510(k) Number K934496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1993
Decision Date December 13, 1993
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K934496.
COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
K940484 · Siemens Medical Solutions USA, Inc. · Apr 1994
DVFX, MODEL M256
K933460 · Xre Corp. · Apr 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
DLX
K926258 · GE Medical Systems · Mar 1993