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510(k) K003325

KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM by Karl Storz Imaging, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2001
Date Received
October 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Karl Storz Imaging, Inc.

  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K994090 — KARL STORZ AUTOCLAVABLE CAMERA HEAD (February 4, 2000)
  • K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (June 1, 1999)
  • K974391 — KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM (January 30, 1998)
  • K973252 — KARL STORZ DIRECT COUPLED CAMERA HEAD (November 24, 1997)
  • K963333 — OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) (October 22, 1996)
  • K950862 — KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVI (May 24, 1995)
  • K950974 — KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TE (May 11, 1995)
  • K950975 — KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY (May 11, 1995)

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