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510(k) K143474

Artemis Hand Held Imaging System by Quest Medical Imaging — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2015
Date Received
December 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

Other clearances by Quest Medical Imaging

  • K141164 — ARTEMIS LIGHT ENGINE (March 16, 2015)

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