Cleared Traditional

K921036 - SONOS 100 ULTRASOUND IMAGING SYSTEM

K921036 is the FDA 510(k) clearance for SONOS 100 ULTRASOUND IMAGING SYSTEM by Hewlett-Packard Co.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K921036 · Hewlett-Packard Co. · Radiology device
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May 1992
Decision
86d
Days
Class 2
Risk

K921036 is an FDA 510(k) clearance for the SONOS 100 ULTRASOUND IMAGING SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 86 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K921036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1992
Decision Date May 29, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
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 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K921036.
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
K922184 · Hewlett-Packard Co. · Jul 1992
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
K915860 · Biosound, Inc. · Jul 1992
ACUSON C366 TRANSDUCER
K911916 · Acuson Corp. · Jun 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