510(k) K071619 ยท IZI System, X-Ray, Angiographic
SPY FLUORESCENT IMAGING SYSTEM
| Applicant | Novadaq Technologies, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Nov 9, 2007 |
| Received | Jun 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071619
| 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 |
| Dec 1, 2014 | Novadaq Technologies, Inc. LUNA Chest, Model No. LU4006 Terminated |
IZI | None listed |
| Dec 1, 2014 | Novadaq Technologies, Inc. Non-sterile drape Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.