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510(k) K182517

MULTIX Impact by Siemens Medi Cal Solutions, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
September 13, 2018
Clearance Type
Traditional
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

Other clearances by Siemens Medi Cal Solutions, Inc.

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  • K181279 — Ysio Max (June 13, 2018)
  • 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)
  • 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 KPR

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  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)