Cleared Traditional

K912416 - ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM

K912416 is an FDA 510(k) clearance for ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM, manufactured by Xre Corp.. 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.

K912416 · Xre Corp. · Radiology device
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Aug 1991
Decision
89d
Days
Class 2
Risk

K912416 is an FDA 510(k) clearance for the ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM. 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 August 28, 1991 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 Xre Corp. devices

FDA 510(k) Submission Details - K912416

510(k) Number K912416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date August 28, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
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 126
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K912416.
HICOR
K914313 · Siemens Gammasonics, Inc. · Nov 1991
UNICATH EP.
K913685 · Xre Corp. · Nov 1991
ADVANCE DISPOSABLE CONTROL SYRINGE
K911732 · Advance Medical Designs, Inc. · Sep 1991
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · Siemens Medical Solutions USA, Inc. · Aug 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370 · Philips Medical Systems, Inc. · May 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · GE Medical Systems · May 1991