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510(k) K994231

SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) by Siemens Medical Corp. — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2000
Date Received
December 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Other clearances by Siemens Medical Corp.

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  • K994316 — MAGNETOM OPEN VIVA WITH PERMANENT MAGNET (January 14, 2000)
  • K984634 — 3D-ANGIO (March 12, 1999)

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  • K100345 — SYSTEMS INTEGRATION MODEL: ENDOALPHA (March 22, 2010)
  • K083598 — KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (May 29, 2009)