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510(k) K091558

BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM by Bioptics, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2009
Date Received
May 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Bioptics, Inc.

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  • K052433 — PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (October 18, 2005)

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