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
K901014Substantially Equivalent

Radiographic Intensifying Screen

Infab, LLC., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901014 is the FDA 510(k) clearance record for RADIOGRAPHIC INTENSIFYING SCREEN, a class I device, cleared for Infab Corp. on under FDA product code EAM (Screen, Intensifying, Radiographic). FDA records list 6 510(k) clearances for Infab Corp., from to . As of , FDA records show no recalls naming K901014.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EAM Screen, Intensifying, Radiographic
Regulation
21 CFR 892.1960
Device class
Class I
Review panel
Radiology
Applicant
Infab Corp. 3651 Via Pescador, Camarillo CA
Third party review
No

Clearances, product code EAM

Trailing 12 months

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

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