Cleared Traditional

K930278 - STORZ COMPUSCAN AB

K930278 is an FDA 510(k) clearance for STORZ COMPUSCAN AB, manufactured by Storz. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K930278 · Storz · Radiology device
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Feb 1994
Decision
384d
Days
Class 2
Risk

K930278 is an FDA 510(k) clearance for the STORZ COMPUSCAN AB. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Storz (St. Louis, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz devices

FDA 510(k) Submission Details - K930278

510(k) Number K930278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date February 09, 1994
Days to Decision 384 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 107d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 543
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