Cleared Traditional

K920678 - ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER

K920678 is an FDA 510(k) clearance for ULTRASOUND IMAGAING SYSTEM AND DOPPLER ..., manufactured by Interspec, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

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

FDA 510(k) Submission Details - K920678

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
Combination Product No
PCCP Authorized No
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.

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 260
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K920678.
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
K920307 · Ausonics Pty , Ltd. · May 1992
SACA, 3.5 MHZ PROBE
K905200 · Diasonics, Inc. · Apr 1992
BIPLANE TRANSRECTAL PROBE
K914006 · Biosound, Inc. · Apr 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
CW DOPPLER 2.25 MHZ PROBE
K903562 · Diasonics, Inc. · Mar 1992