510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943381Substantially Equivalent

Laser Alignment Tool

Philips North America LLC, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943381 is the FDA 510(k) clearance record for LASER ALIGNMENT TOOL, a class I device, cleared for Philips Medical Systems North America, Inc. on under FDA product code IWE (Monitor, Patient Position, Light-Beam). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K943381.

Clearance record

Decision date
Received
(27 days to decision)
Product code
IWE Monitor, Patient Position, Light-Beam
Regulation
21 CFR 892.5780
Device class
Class I
Review panel
Radiology
Applicant
Philips Medical Systems North America, Inc. 710 Bridgeport Ave., Shelton CT
510(k) summary
Summary
Third party review
No

Clearances, product code IWE

Trailing 12 months

FDA records hold no clearances under product code IWE in the trailing twelve months.

FDA records show no clearances under product code IWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260