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510(k) K190729

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

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
April 19, 2019
Date Received
March 21, 2019
Clearance Type
Special
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)
  • K192174 — SPY Portable Handheld Imaging (SPY-PHI) System (November 15, 2019)
  • K182907 — SPY Elite Intraoperative Perfusion Assessment System (January 23, 2019)
  • K182606 — PINPOINT Endoscopic Fluorescence Imaging System (November 21, 2018)

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