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510(k) K080890

SMARTSPOT PRIMAX by Cmt Medical Technologies, Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2008
Date Received
March 31, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K991578 — SMARTSPOT 2000 (June 3, 1999)
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  • K961307 — SMART SPOT (July 1, 1996)

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