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510(k) K864958

ALPHA II DIAGNOSTIC X-RAY by Ausonics Pty , Ltd. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1987
Date Received
December 18, 1986
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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