510(k) K063345 ยท IZI System, X-Ray, Angiographic
SPY IMAGING SYSTEM
| Applicant | Novadaq Technologies, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Jan 12, 2007 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2016 | NOVADAQ TECHNOLOGIES INC. 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 Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.