510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K970293Substantially Equivalent

Fuji Computed Radiography Fcr/dicom Gateway Unit Cr-Dm666

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

K970293 is the FDA 510(k) clearance record for FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666, a class I device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code LMD (System, Digital Image Communications, Radiological). FDA's definition for product code LMD reads: "A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple...". FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K970293.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LMD System, Digital Image Communications, Radiological
Regulation
21 CFR 892.2020
Device class
Class I
Review panel
Radiology
Applicant
Fujifilm Medical System U.S.A., Inc. 333 Ludlow St., Stamford CT
510(k) summary
Summary
Third party review
No

Clearances, product code LMD

Trailing 12 months

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

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