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510(k) K091928

10 X 10 VISION by Bioptics, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2010
Date Received
June 30, 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

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

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