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510(k) K141164

ARTEMIS LIGHT ENGINE by Quest Medical Imaging — Product Code NTN

K141164 is an FDA 510(k) premarket notification submitted by Quest Medical Imaging for the device "ARTEMIS LIGHT ENGINE". The FDA issued a decision of Substantially Equivalent on March 16, 2015. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Quest Medical Imaging has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2015
Date Received
May 5, 2014
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 Quest Medical Imaging

  • K143474 — Artemis Hand Held Imaging System (June 30, 2015)

Other clearances for product code NTN

  • K133311 — ENDOLED (July 30, 2014)
  • K130819 — CLL- V1 LIGHT SOURCE (June 19, 2013)
  • K122831 — VIDEO SYSTEM CENTER (December 14, 2012)
  • 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