510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042540Substantially Equivalent

Philips Iu22 Ultrasound System

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

K042540 is the FDA 510(k) clearance record for PHILIPS IU22 ULTRASOUND SYSTEM, a class II device, cleared for Philips Ultrasound, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 4 recalls naming K042540.

Clearance record

Decision date
Received
(14 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Philips Ultrasound, Inc. 22100 Bothell Everett Hwy., Bothell WA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260