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510(k) K042961

SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 by Novadaq Technologies, Inc. — Product Code IZI

K042961 is an FDA 510(k) premarket notification submitted by Novadaq Technologies, Inc. for the device "SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000". The FDA issued a decision of Substantially Equivalent on January 19, 2005. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Novadaq Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2005
Date Received
October 27, 2004
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, Inc.

  • K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System (January 11, 2017)
  • K161792 — PINPOINT Endoscopic Fluorescence Imaging System (September 20, 2016)
  • K150956 — PINPOINT Endoscopic Fluorescence Imaging System (May 23, 2016)
  • K123013 — ENDOSCOPIC INTRODUCER (March 22, 2013)
  • K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM (February 4, 2011)
  • K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (July 9, 2009)
  • K081792 — SPY ANALYSIS TOOLKIT, MODEL SA9000 (September 17, 2008)
  • K073088 — SPY FLUORESCENT IMAGING SYSTEM (January 10, 2008)
  • K073130 — SPY FLUORESCENT IMAGING SYSTEM (January 10, 2008)
  • K071619 — SPY FLUORESCENT IMAGING SYSTEM (November 9, 2007)

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)
  • 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)

FDA data resources