510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850813Substantially Equivalent

Mobile Lead Plastic X-Ray Barriers

Victoreen, Inc., Carle Place NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850813 is the FDA 510(k) clearance record for MOBILE LEAD PLASTIC X-RAY BARRIERS, a class I device, cleared for Victoreen, Inc. on under FDA product code IWX (Barrier, Control Panel, X-Ray, Movable). FDA records list 40 510(k) clearances for Victoreen, Inc., from to . As of , FDA records show no recalls naming K850813.

Clearance record

Decision date
Received
(41 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
Victoreen, Inc. 100 Voice Rd., Carle Place NY
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