Spy Fluorescent Imaging System
FDA 510(k) K072222 · Novadaq Technologies, Inc.
510(k) numberK072222
Submission
- Device name
- Spy Fluorescent Imaging System
- Applicant
- Novadaq Technologies, Inc.
Mississauga, Ontario, CA - Received
- August 10, 2007
- Decision date
- September 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Surgvision GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging SystemOWN · Traditional | 01/11/2017SE |
| K161792 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Special | 09/20/2016SE |
| K150956 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Traditional | 05/23/2016SE |
| K123013 | Endoscopic IntroducerFED · Traditional | 03/22/2013SE |
| K100371 | Spy Intra-Operative Imaging SystemIZI · Traditional | 02/04/2011SE |
| K091515 | Spy Scope Intra-Operative Operating SystemGCJ · Traditional | 07/09/2009SE |
| K081792 | Spy Analysis Toolkit, Model SA9000LLZ · Traditional | 09/17/2008SE |
| K073130 | Spy Fluorescent Imaging SystemIZI · Traditional | 01/10/2008SE |
| K073088 | Spy Fluorescent Imaging SystemIZI · Traditional | 01/10/2008SE |
| K071619 | Spy Fluorescent Imaging SystemIZI · Traditional | 11/09/2007SE |
Questions and answers
When was Spy Fluorescent Imaging System cleared by the FDA?
Spy Fluorescent Imaging System (K072222) received a 510(k) decision of Substantially Equivalent on September 7, 2007, 28 days after the submission was received.
What is the product code of K072222?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.