Cleared Traditional

SONOSCAN (K961692) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961692 · Sonotech, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
113d
Days
Class 2
Risk

K961692 is an FDA 510(k) clearance for the SONOSCAN. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 113 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 Sonotech, Inc. devices

Submission Details

510(k) Number K961692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date August 22, 1996
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 107d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K961692.
VIEWCATH 3-D CATHETER PULLBACK
K971397 · Quinton, Inc. · Aug 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · Hewlett-Packard Co. · Jul 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · Hewlett-Packard Co. · Mar 1997
GE B510 TRANSDUCER
K951723 · GE Medical Systems · Nov 1995
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · Boston Scientific Corp · Dec 1994
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · Boston Scientific Corp · Nov 1992