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510(k) K061284

I-CAT SCANNER by Imaging Sciences Intl., Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2006
Date Received
May 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
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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