Cleared Traditional

K901655 - 1 TRANSDUCER FOR COMBISON 310A

K901655 is an FDA 510(k) clearance for 1 TRANSDUCER FOR COMBISON 310A, 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 102-day FDA review.

K901655 · Kretztechnik AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
102d
Days
Class 2
Risk

K901655 is an FDA 510(k) clearance for the 1 TRANSDUCER FOR COMBISON 310A. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Kretztechnik AG (Solon, US). The FDA issued a Cleared decision on July 20, 1990 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Kretztechnik AG devices

FDA 510(k) Submission Details - K901655

510(k) Number K901655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date July 20, 1990
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
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
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K901655.
RADIUS AND SONOCHROME
K902070 · General Electric Co. · Aug 1990
ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500
K896644 · Shimadzu Corp. · Aug 1990
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
K897073 · Shimadzu Corp. · Aug 1990
ACUSON L538 TRANSDUCER
K893863 · Acuson Computed Sonography · May 1990
FUJINON EDU SYSTEM
K894763 · Fujinon, Inc. · May 1990
B-SCAN 10 MHZ PROBE
K896038 · Teknar, Inc. · Apr 1990