510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043535Substantially Equivalent

Hd11 Diagnostic Ultrasound System

Philips North America LLC, Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043535 is the FDA 510(k) clearance record for HD11 DIAGNOSTIC ULTRASOUND SYSTEM, a class II device, cleared for Philips Ultrasound, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 36 recalls naming K043535.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Philips Ultrasound, Inc. 3000 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

Trailing 12 months
52 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20260