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510(k) K122831

VIDEO SYSTEM CENTER by Olympus Medical Systems Corp. — Product Code NTN

K122831 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "VIDEO SYSTEM CENTER". The FDA issued a decision of Substantially Equivalent on December 14, 2012. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2012
Date Received
September 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Led Light Source
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

Other clearances by Olympus Medical Systems Corp.

  • K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 (July 1, 2026)
  • K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX (May 21, 2026)
  • K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOS (April 23, 2026)
  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315) (February 22, 2026)
  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)

Other clearances for product code NTN

  • K141164 — ARTEMIS LIGHT ENGINE (March 16, 2015)
  • K133311 — ENDOLED (July 30, 2014)
  • K130819 — CLL- V1 LIGHT SOURCE (June 19, 2013)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K103813 — SOPRO 281 (March 22, 2011)
  • K102167 — LO-50 LED LIGHT SOURCE (August 17, 2010)
  • K091829 — PLS PORTABLE LIGHT SOURCE (July 28, 2009)
  • K090601 — FSC 2 (May 11, 2009)

FDA data resources