Cleared Traditional

K955327 - HP SONOS 100CF ULTRASOUND IMAGING SYSTEM

K955327 is an FDA 510(k) clearance for HP SONOS 100CF ULTRASOUND IMAGING SYSTEM, manufactured by Hewlett-Packard Co.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K955327 · Hewlett-Packard Co. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
140d
Days
Class 2
Risk

K955327 is an FDA 510(k) clearance for the HP SONOS 100CF 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 April 8, 1996 after a review of 140 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K955327

510(k) Number K955327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date April 08, 1996
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 1112
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K955327.
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K960602 · Toshiba America Medical Systems, In.C · Mar 1996
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K946277 · Tetra Corp. · Mar 1996