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510(k) K181279

Ysio Max by Siemens Medi Cal Solutions, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2018
Date Received
May 15, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K171766 — Acuson SC2000 Diagnostic Ultrasound System (July 12, 2017)
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  • K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit (November 22, 2016)
  • K162417 — Acuson Freestyle Ultrasound System (September 28, 2016)

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