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510(k) K182907

SPY Elite Intraoperative Perfusion Assessment System by Novadaq Technologies Ulc. (Now A Part of Stryker) — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2019
Date Received
October 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Novadaq Technologies Ulc. (Now A Part of Stryker)

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  • 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)
  • K182606 — PINPOINT Endoscopic Fluorescence Imaging System (November 21, 2018)

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  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)
  • K192761 — Asimov-MKS Imaging System (January 17, 2020)