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510(k) K896596

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL by Instrumentarium Imaging, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1991
Date Received
November 21, 1989
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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  • K925987 — INSTRUMENTARIUM MEGA4 HT (May 19, 1993)
  • K924921 — INSTRUMENTARIUM MEGA4 HT (May 17, 1993)
  • K924472 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923581 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)

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