Home / 510(k) Clearances / K090800

510(k) K090800

VS-100 ILLUMINATION AND IMAGING SYSTEM by Schoelly Imaging, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2009
Date Received
March 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Schoelly Imaging, Inc.

  • K090601 — FSC 2 (May 11, 2009)
  • K083553 — NASO-LARYNGO-PHARYNGOSCOPE (January 16, 2009)
  • K060899 — FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (March 2, 2007)
  • K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC (February 23, 2006)

Other clearances for product code FET

  • K251734 — ProVee Video Processing Unit (PV-003) (September 24, 2025)
  • K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (August 11, 2025)
  • K250204 — Endoscopic Camera System (July 1, 2025)
  • K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (April 11, 2025)
  • K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH (April 2, 2025)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 2024)
  • K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (July 3, 2024)
  • K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100D (April 26, 2023)
  • K212808 — Logic Hd camera head green, System green (June 14, 2022)