SPY FLUORESCENT IMAGING SYSTEM— 510(k) K071619
Substantially EquivalentNovadaq Technologies, Inc.
FDA 510(k) clearance K071619 for SPY FLUORESCENT IMAGING SYSTEM, Substantially Equivalent on 2007-11-09. Applicant: Novadaq Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Novadaq Technologies, Inc.
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, Ontario, CA
Recent devices under product code IZI
view allMore clearances from Novadaq Technologies, Inc.
view allAdverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071619
K-number listed on FDA's recall record- 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.
- Z-0469-2015 — LUNA Chest, Model No. LU4006
- Z-0470-2015 — Non-sterile drape
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071619.
Data sourced from openFDA. This site is unofficial and independent of the FDA.