Cleared Traditional

K973368 - STRAIT'MAP OPTION

K973368 is an FDA 510(k) clearance for STRAIT'MAP OPTION, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K973368 · Ge Medical Systems, Inc. · Radiology device
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Oct 1997
Decision
39d
Days
Class 2
Risk

K973368 is an FDA 510(k) clearance for the STRAIT'MAP OPTION. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 17, 1997 after a review of 39 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 Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K973368

510(k) Number K973368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date October 17, 1997
Days to Decision 39 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
68d faster than avg
Panel avg: 107d · This submission: 39d
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 114
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K973368.
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