510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K033377Substantially Equivalent

Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and Fm-Dp L

FUJIFILM Healthcare Americas Corporation, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033377 is the FDA 510(k) clearance record for FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K033377.

Clearance record

Decision date
Received
(79 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Fujifilm Medical System U.S.A., Inc. 419 W. Ave., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LMC

Trailing 12 months

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

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