Cleared Traditional

K903562 - CW DOPPLER 2.25 MHZ PROBE

K903562 is an FDA 510(k) clearance for CW DOPPLER 2.25 MHZ PROBE, manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 573-day FDA review.

K903562 · Diasonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
573d
Days
Class 2
Risk

K903562 is an FDA 510(k) clearance for the CW DOPPLER 2.25 MHZ PROBE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Diasonics, Inc. (Milipitas, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 573 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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K903562

510(k) Number K903562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date March 02, 1992
Days to Decision 573 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
466d slower than avg
Panel avg: 107d · This submission: 573d
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 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K903562.
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
PSF-50ET
K910850 · Toshiba America Medical Systems, In.C · Jan 1992
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · Biosound, Inc. · Dec 1991
ACUSON V510 TRANSDUCER
K911767 · Acuson Corp. · Oct 1991