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510(k) K051980

DVT SCANNER by Imaging Sciences Intl., Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
July 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K981466 — XR-910 (July 14, 1998)
  • K931815 — 2000 X-RAY - TOMOGRAPHIC (August 23, 1993)

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