510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K030781Substantially Equivalent

Kodak Directview Pacs/image Management System, Kodak Directview Workflow Manager,kodak Directview Cx/dx, Kodak Directvib

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

K030781 is the FDA 510(k) clearance record for KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB, a class II device, cleared for Eastman Kodak Company on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K030781.

Clearance record

Decision date
Received
(79 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Eastman Kodak Company 47315 Mission Falls Ct., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLZ

Trailing 12 months
46 clearances under product code LLZ in the twelve months to November 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20262
November 20260