Cleared Traditional

ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (K920678) - FDA 510(k) Clearance

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

K920678 · Interspec, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
48d
Days
Class 2
Risk

K920678 is an FDA 510(k) clearance for the ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Interspec, Inc. (Ambler, US). The FDA issued a Cleared decision on April 2, 1992 after a review of 48 days - a notably fast clearance cycle.

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: 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 Interspec, Inc. devices

Submission Details

510(k) Number K920678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1992
Decision Date April 02, 1992
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
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 100
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K920678.
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · Boston Scientific Corp · Nov 1992
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
K922184 · Hewlett-Packard Co. · Jul 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
SONOLAYER ALPHA, MODEL SSH-140A
K913798 · Toshiba America Medical Systems, In.C · Apr 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · Baxter Healthcare Corp · Mar 1992
PSF-50ET
K910850 · Toshiba America Medical Systems, In.C · Jan 1992