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5 MHz Doppler Outrigger

by Philips Ultrasound, Inc.

510(k) K872817

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872817 Date8 Feb 1988ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYN
Device class
Class II
Regulation
21 CFR Part 892.1550
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a 5 MHz Doppler outrigger, which is an ultrasound system used in radiology. It is a Class II ultrasound system manufactured by Philips Ultrasound, Inc.

It received FDA 510(k) clearance under K872817 on February 8, 1988, and is substantially equivalent to a predicate device. The device is supplied by Philips Ultrasound, Inc., located in Santa Ana, CA.

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