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510(k) K171766

Acuson SC2000 Diagnostic Ultrasound System by Siemens Medi Cal Solutions, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2017
Date Received
June 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (April 2, 2018)
  • K173408 — Mammomat Revelation (March 21, 2018)
  • K172832 — Insight BD (February 6, 2018)
  • 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)

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