Cleared Traditional

K954028 - HP SONOS ULTRASOUND IMAGING SYSTEM (FDA 510(k) Clearance)

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

K954028 · Hewlett-Packard Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
346d
Days
Class 2
Risk

K954028 is an FDA 510(k) clearance for the HP SONOS ULTRASOUND IMAGING SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K954028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date August 08, 1996
Days to Decision 346 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
239d slower than avg
Panel avg: 107d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1158
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K954028.
ES-Series
K260589 · E-Scopics · Apr 2026
6450 Ultrasound System (MyLabE80)
K253288 · Esaote, S.P.A. · Apr 2026
Wireless Probe Type Ultrasound Scanner
K252709 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Apr 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · Samsung Medison Co., Ltd. · Mar 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K253595 · Philips Ultrasound, LLC · Mar 2026
Butterfly Gestational Age Tool
K252148 · Butterfly Network, Inc. · Mar 2026