IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}— 510(k) K973421

Substantially Equivalent

Dejarnette Research Systems

FDA 510(k) clearance K973421 for IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}, Substantially Equivalent on 1997-12-05. Applicant: Dejarnette Research Systems. Device class: 1.

Clearance details

Applicant
Dejarnette Research Systems
Product code
Code LMD
Device class
Class 1
Regulation
21 CFR 892.2020
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Towson, MD, US
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