# K081792: Spy Analysis Toolkit, Model SA9000

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Sep 17, 2008 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945512 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080290: Xviewnet, American Radiologist Network, Inc. (2008) Summary page 1.
- K061671: Syngo Trued, Model VC10A, Siemens Medical Solutions (2006) Summary page 1.
- K063107: 3DNET Suite, Biotronics3D, Ltd. (2006) Summary page 1.

## Indications for use
The SPY Analysis Toolkit is a separate companion software application to the SPY Intra-operative Imaging System and is intended as a display, analysis, and comparison tool for the interpretation of SPY images by trained healthcare professionals including cardiovascular, plastic & reconstructive, and organ transplant surgeons. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images. The SPY Analysis Toolkit is a complement to the SPY procedures.

Source page: https://510kreport.com/device/K081792
Methodology: https://510kreport.com/methodology