Cleared Traditional

K914313 - HICOR

K914313 is an FDA 510(k) clearance for HICOR, manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K914313 · Siemens Gammasonics, Inc. · Radiology device
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Nov 1991
Decision
65d
Days
Class 2
Risk

K914313 is an FDA 510(k) clearance for the HICOR. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 65 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 Gammasonics, Inc. devices

FDA 510(k) Submission Details - K914313

510(k) Number K914313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date November 27, 1991
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 101
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K914313.
POLYTRON DIGITAL IMAGING SYSTEM
K920705 · Siemens Medical Solutions USA, Inc. · Apr 1992
DXS DIGITAL X-RAY SUBTRACTION
K914376 · Philips Medical Systems (Cleveland), Inc. · Feb 1992
STORZ IMAGING SYSTEM
K915199 · Fischer Imaging Corp. · Jan 1992
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