Cleared Traditional

DOPPLER OPTION FOR PLATINUM (K902691) - FDA 510(k) Clearance

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

K902691 · Philips Medical Systems, Inc. · Radiology device
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Jan 1991
Decision
197d
Days
Class 2
Risk

K902691 is an FDA 510(k) clearance for the DOPPLER OPTION FOR PLATINUM. 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 Philips Medical Systems, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 2, 1991 after a review of 197 days - an extended review cycle.

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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K902691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date January 02, 1991
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
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 541
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K902691.
PHILIPS ULTRASOUND P800 IMAGING SYSTEM
K935923 · Hewlett-Packard Co. · Dec 1994
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION
K934041 · Hewlett-Packard Co. · Sep 1994
VENUS DIAGNOSTIC ULTRASOUND SYSTEM
K933202 · GE Medical Systems · Jun 1994
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984