Spy Analysis Toolkit, Model SA9000
FDA 510(k) K081792 · Novadaq Technologies, Inc.
510(k) numberK081792
Submission
- Device name
- Spy Analysis Toolkit, Model SA9000
- Applicant
- Novadaq Technologies, Inc.
Mississauga, Ontario, CA - Received
- June 25, 2008
- Decision date
- September 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 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 |
| 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 Analysis Toolkit, Model SA9000 cleared by the FDA?
Spy Analysis Toolkit, Model SA9000 (K081792) received a 510(k) decision of Substantially Equivalent on September 17, 2008, 84 days after the submission was received.
What is the product code of K081792?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.