510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963594Substantially Equivalent

Imageshare Secondary Capture Acquisition Station And/or Software (1000 Film Digitizer Acquisition Station)

Dejarnette Research Systems, Towson MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963594 is the FDA 510(k) clearance record for IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION), a class I device, cleared for Dejarnette Research Systems 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 9 510(k) clearances for Dejarnette Research Systems, from to . As of , FDA records show no recalls naming K963594.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LMD System, Digital Image Communications, Radiological
Regulation
21 CFR 892.2020
Device class
Class I
Review panel
Radiology
Applicant
Dejarnette Research Systems 401 Washington Ave., Towson MD
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMD, 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