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510(k) K981641

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ by Instrumentarium Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
May 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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