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510(k) K202244

SPY-PHI System with SPY-PHI Fluorescence Assessment Software by Novadaq Technologies Ulc. (Now A Part of Stryker) — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2020
Date Received
August 10, 2020
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)

  • K200737 — SPY Portable Handheld Imaging (SPY-PHI) System (May 21, 2020)
  • K192174 — SPY Portable Handheld Imaging (SPY-PHI) System (November 15, 2019)
  • 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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