510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K090469Substantially Equivalent

Carestream Dryview 5850 Laser Imager

Eastman Kodak Company, Oakdale MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090469 is the FDA 510(k) clearance record for CARESTREAM DRYVIEW 5850 LASER IMAGER, a class II device, cleared for Carestream Health, Inc. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 291 510(k) clearances for EASTMAN KODAK COMPANY, from to . As of , FDA records show no recalls naming K090469.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Carestream Health, Inc. 1 Imation Way, Oakdale MN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMC, 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