510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K922848Substantially Equivalent

Ultralite X-Ray Film Illuminator

A & S Trading Co., Fort Mill SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922848 is the FDA 510(k) clearance record for ULTRALITE X-RAY FILM ILLUMINATOR, a class I device, cleared for A & S Trading Co. on under FDA product code IXC (Illuminator, Radiographic-Film). FDA records list one 510(k) clearance for A & S Trading Co. As of , FDA records show no recalls naming K922848.

Clearance record

Decision date
Received
(102 days to decision)
Product code
IXC Illuminator, Radiographic-Film
Regulation
21 CFR 892.1890
Device class
Class I
Review panel
Radiology
Applicant
A & S Trading Co. 377 Carowinds Blvd., Fort Mill SC
510(k) summary
Statement
Third party review
No

Clearances, product code IXC

Trailing 12 months

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

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