Spy Intra-Operative Imaging System, Model SP2000
FDA 510(k) K071037 · Novadaq Technologies, Inc.
510(k) numberK071037
Submission
- Device name
- Spy Intra-Operative Imaging System, Model SP2000
- Applicant
- Novadaq Technologies, Inc.
Mississauga, Ontario, CA - Received
- April 12, 2007
- Decision date
- May 10, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 Intra-Operative Imaging System, Model SP2000 cleared by the FDA?
Spy Intra-Operative Imaging System, Model SP2000 (K071037) received a 510(k) decision of Substantially Equivalent on May 10, 2007, 28 days after the submission was received.
What is the product code of K071037?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.