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510(k) K931815

2000 X-RAY - TOMOGRAPHIC by Imaging Sciences Intl., Inc. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
April 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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