Cleared Traditional

K910966 - SECTOR TRANSDUCER MODEL NO. AWP3.5/A

K910966 is an FDA 510(k) clearance for SECTOR TRANSDUCER MODEL NO. AWP3.5/A, manufactured by Kretztechnik AG. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K910966 · Kretztechnik AG · Radiology device
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Apr 1992
Decision
408d
Days
Class 2
Risk

K910966 is an FDA 510(k) clearance for the SECTOR TRANSDUCER MODEL NO. AWP3.5/A. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Kretztechnik AG (Austria, AT). The FDA issued a Cleared decision on April 17, 1992 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Kretztechnik AG devices

FDA 510(k) Submission Details - K910966

510(k) Number K910966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date April 17, 1992
Days to Decision 408 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 107d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 351
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