Spy Intra-Operative Imaging System
FDA 510(k) K100371 · Novadaq Technologies, Inc.
510(k) numberK100371
Submission
- Device name
- Spy Intra-Operative Imaging System
- Applicant
- Novadaq Technologies, Inc.
Mississauga, Ontario, CA - Received
- February 12, 2010
- Decision date
- February 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| K072222 | Spy Fluorescent Imaging SystemIZI · Special | 09/07/2007SE |
Questions and answers
When was Spy Intra-Operative Imaging System cleared by the FDA?
Spy Intra-Operative Imaging System (K100371) received a 510(k) decision of Substantially Equivalent on February 4, 2011, 357 days after the submission was received.
What is the product code of K100371?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.