Home / 510(k) Clearances / K173408

510(k) K173408

Mammomat Revelation by Siemens Medi Cal Solutions, Inc. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2018
Date Received
November 1, 2017
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

Other clearances by Siemens Medi Cal Solutions, Inc.

  • K193216 — syngo.CT Lung CAD (March 9, 2020)
  • K182639 — MOBILETT Elara Max (March 15, 2019)
  • K182517 — MULTIX Impact (January 11, 2019)
  • K181279 — Ysio Max (June 13, 2018)
  • K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (April 2, 2018)
  • K172832 — Insight BD (February 6, 2018)
  • K171766 — Acuson SC2000 Diagnostic Ultrasound System (July 12, 2017)
  • K170315 — Acuson SC2000 Diagnostic Ultrasound System (April 4, 2017)
  • K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit (November 22, 2016)
  • K162417 — Acuson Freestyle Ultrasound System (September 28, 2016)

Other clearances for product code MUE

  • K243420 — HESTIA (July 17, 2025)
  • K243849 — 2430TCA with Xmaru W (March 12, 2025)
  • K241113 — VIVIX-M (January 16, 2025)
  • K233539 — MAMMOMAT B.brilliant (March 27, 2024)
  • K220073 — RMF-2000 (January 26, 2023)
  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K212873 — Aspire Cristalle (May 27, 2022)
  • K210151 — Digimamo D (March 1, 2022)
  • K202822 — Helianthus (December 15, 2021)
  • K211725 — Senographe Pristina (August 6, 2021)