Cleared Traditional

K971116 - SONOS 5500 IMAGING SYSTEM

K971116 is the FDA 510(k) clearance for SONOS 5500 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 292-day FDA review.

K971116 · Hewlett-Packard Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
292d
Days
Class 2
Risk

K971116 is an FDA 510(k) clearance for the SONOS 5500 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 January 12, 1998 after a review of 292 days - an extended review 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: 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

Submission Details

510(k) Number K971116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date January 12, 1998
Days to Decision 292 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
185d slower than avg
Panel avg: 107d · This submission: 292d
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 K971116.
EUP-OL334 LAPARASCOPICPROBE
K981434 · Hitachi Medical Corp. of America · Jul 1998
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
K974544 · Aloka Co., Ltd. · Mar 1998
PHASED ARRAY TRANSDUCER - - PVF -375DT
K972771 · Toshiba America Medical Systems, In.C · Feb 1998
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · Acuson Corp. · Nov 1997
VIEWCATH 3-D CATHETER PULLBACK
K971397 · Quinton, Inc. · Aug 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · Hewlett-Packard Co. · Jul 1997