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510(k) K192174

SPY Portable Handheld Imaging (SPY-PHI) System by Novadaq Technologies Ulc. (Now A Part of Stryker) — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
August 12, 2019
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 Novadaq Technologies Ulc. (Now A Part of Stryker)

  • K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software (November 5, 2020)
  • K200737 — SPY Portable Handheld Imaging (SPY-PHI) System (May 21, 2020)
  • K190729 — SPY Portable Handheld Imaging (SPY-PHI) System (April 19, 2019)
  • K182907 — SPY Elite Intraoperative Perfusion Assessment System (January 23, 2019)
  • K182606 — PINPOINT Endoscopic Fluorescence Imaging System (November 21, 2018)

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