510(k) K071037 ยท IZI System, X-Ray, Angiographic
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
| Applicant | Novadaq Technologies, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, May 10, 2007 |
| Received | Apr 12, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071037
| 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.