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510(k) K230727

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

K230727 is an FDA 510(k) premarket notification submitted by Novadaq Technologies Ulc (A Part of Stryker) for the device "SPY Portable Handheld Imaging (SPY-PHI) System". The FDA issued a decision of Substantially Equivalent on June 5, 2023. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2023
Date Received
March 16, 2023
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 for product code IZI

  • K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (May 28, 2026)
  • K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform (May 13, 2026)
  • K243645 — IC-Flow™ Imaging System 2.0 (September 22, 2025)
  • K243077 — Affirm 800 (June 27, 2025)
  • K231986 — Modus IR (March 25, 2024)
  • K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (March 20, 2024)
  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)

FDA data resources