Cleared Traditional

HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM (K922184) - FDA 510(k) Clearance

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

K922184 · Hewlett-Packard Co. · Radiology device
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Jul 1992
Decision
80d
Days
Class 2
Risk

K922184 is an FDA 510(k) clearance for the HP SONOS 100 CF 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 July 30, 1992 after a review of 80 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 K922184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date July 30, 1992
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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 74
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K922184.
GE B510 TRANSDUCER
K951723 · GE Medical Systems · Nov 1995
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K940108 · Boston Scientific Corp · Dec 1994
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K913890 · Boston Scientific Corp · Nov 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · Baxter Healthcare Corp · Mar 1992
SONICATH(TM) 9F, 12 MHZ
K902245 · Boston Scientific Corp · Oct 1990