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510(k) K052433

PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM by Bioptics, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2005
Date Received
September 6, 2005
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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  • K082432 — CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (November 21, 2008)

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