510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881591Substantially Equivalent

A2j Mz 45 Laser Light for Positioning

A2j, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881591 is the FDA 510(k) clearance record for A2J MZ 45 LASER LIGHT FOR POSITIONING, a class I device, cleared for A2j, Inc. on under FDA product code IWX (Barrier, Control Panel, X-Ray, Movable). FDA records list 2 510(k) clearances for A2j, Inc., from to . As of , FDA records show no recalls naming K881591.

Clearance record

Decision date
Received
(14 days to decision)
Product code
IWX Barrier, Control Panel, X-Ray, Movable
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
A2j, Inc. 10500 Richmond Suite 201, Houston TX
Third party review
No

Clearances, product code IWX

Trailing 12 months

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

FDA records show no clearances under product code IWX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWX, 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