510(k) · Cleared
ClearedSpy Analysis Toolkit, Model SA9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 17, 2008 as substantially equivalent to K080290 (American Radiologist Network, Inc., 2008) and 2 other predicates after an 84-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 17, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K945512 (1995). 41 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 7 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 6 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 5 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 4 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 3 generations backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- 2 generations backK052345 Advantage Sim MDGE Healthcare · 2005 · Recalled
- 1 generation backK061671 Syngo Trued, Model VC10ASiemens Medical Solutions · 2006
- This deviceK081792 Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −7 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −6 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −5 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −4 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −3 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| −2 | K052345 | Advantage Sim MD | GE Healthcare | 2005 | 3 |
| −1 | K061671 | Syngo Trued, Model VC10A | Siemens Medical Solutions | 2006 | — |
| 0 (this device) | K081792 | Spy Analysis Toolkit, Model SA9000 | Novadaq Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080290 | XviewnetSummary page 1…nformation for three of these demonstrates substantial equivalence. These commercial products include: 1. American Radiologist Network xViewNet cleared for market via K080290 Trade Name: xViewNet Product Code: LLZ 2. Siemens syngo TrueD, Model VC1OA cleared for market via K061671 Tr… | 2008 |
| * | K061671 | Syngo Trued, Model VC10ASummary page 1…iologist Network xViewNet cleared for market via K080290 Trade Name: xViewNet Product Code: LLZ 2. Siemens syngo TrueD, Model VC1OA cleared for market via K061671 Trade Name: Siements syngo TrueD, Model VC1OA Product Code: LLZ 3. Biotronics3D 3Dnet Suite cleared for market via… | 2006 |
| * | K063107 | 3DNET SuiteSummary page 1…el VC1OA cleared for market via K061671 Trade Name: Siements syngo TrueD, Model VC1OA Product Code: LLZ 3. Biotronics3D 3Dnet Suite cleared for market via K063107 Trade Name: Biotronics3D 3Dnet Suite Product Code: LLZ In each of these software devices, including the SPY Analysis… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 13 of the 41 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081792: Spy Analysis Toolkit, Model SA9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081792
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026