510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874778Substantially Equivalent

Kodak Ektascan Image Transmission Syst T1/r1 Sftwr

Eastman Kodak Company, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874778 is the FDA 510(k) clearance record for KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR, a class II device, cleared for Eastman Kodak Company on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K874778.

Clearance record

Decision date
Received
(462 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Eastman Kodak Company 343 State St., Rochester NY
Third party review
No

Clearances, product code LMA

Trailing 12 months

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

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