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510(k) K964274

WRITESTAR, AND VIEWSTAR by Comview Corp. — Product Code LMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
October 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Digital Image Storage, Radiological
Device Class
Class I
Regulation Number
892.2010
Review Panel
RA
Submission Type

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

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  • K971848 — TDK MEDICAL GRADE CD-R (August 15, 1997)
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