Name: Predicase
Price: 199 USD

K-number	K963594
Device name	IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
Applicant	Dejarnette Research Systems
Product code	LMD
Device class	Class I
Decision date	Nov 7, 1996
Decision	Substantially Equivalent
Regulation	892.2020

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View the full FDA submission: accessdata.fda.gov

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IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)

Everything you need for a 510(k) submission. Nothing you don't.