510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021903Substantially Equivalent

Kodak X-Omat Cassette/leadless for Dental Use

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

K021903 is the FDA 510(k) clearance record for KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE, a class II device, cleared for Eastman Kodak Company on under FDA product code IXA (Cassette, Radiographic Film). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K021903.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
Eastman Kodak Company 1669 Lake Ave., Rochester NY
510(k) summary
Statement
Third party review
No

Clearances, product code IXA

Trailing 12 months

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

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