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510(k) K111324

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER by Agfa Healthcare N.V. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2011
Date Received
May 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

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  • K142184 — DX-D IMAGING PACKAGE (October 16, 2014)

Other clearances for product code MUE

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  • K220073 — RMF-2000 (January 26, 2023)
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  • K212873 — Aspire Cristalle (May 27, 2022)
  • K210151 — Digimamo D (March 1, 2022)
  • K202822 — Helianthus (December 15, 2021)
  • K211725 — Senographe Pristina (August 6, 2021)