SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000— 510(k) K071037

Clearance details

Applicant

Novadaq Technologies, Inc.

Product code

Code IZI

Device class

Class 2

Regulation

21 CFR 892.1600

Advisory panel

Radiology

Date received

2007-04-12

Decision date

2007-05-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Mississauga, Ontario, CA

• K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
• K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
• K243645 — IC-Flow Imaging System 2.02025-09-22
• K243077 — Affirm 8002025-06-27
• K231986 — Modus IR2024-03-25

• K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System2017-01-11
• K161792 — PINPOINT Endoscopic Fluorescence Imaging System2016-09-20
• K150956 — PINPOINT Endoscopic Fluorescence Imaging System2016-05-23
• K123013 — ENDOSCOPIC INTRODUCER2013-03-22
• K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM2011-02-04

Death

9

Malfunction

5,312

Total

5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2767-2016 — Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.Class II·Terminated·NOVADAQ TECHNOLOGIES INC.·20160818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071037.