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510(k) K162885

SPY Phi Open Field Handheld Fluorescence Imaging System by Novadaq Technologies, Inc. — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2017
Date Received
October 17, 2016
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.

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  • K073088 — SPY FLUORESCENT IMAGING SYSTEM (January 10, 2008)
  • K071619 — SPY FLUORESCENT IMAGING SYSTEM (November 9, 2007)
  • K072222 — SPY FLUORESCENT IMAGING SYSTEM (September 7, 2007)

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