510(k) · Cleared
ClearedLeica Model FL800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Microsystems, Inc. · IZI System, X-Ray, Angiographic
Cleared on Sep 20, 2006 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) after a 79-day review. Its family tree reaches back 2 generations to 1994. 133 later devices descend from it.
- Decided
- Sep 20, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944261 (1994). 3 ancestors in all. 133 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 1 generation backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- This deviceK061871 Leica Model FL800Leica Microsystems, Inc. · 2006
- Descendant · cites it directly · 131 of its ownK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- Descendant · cites it directly · 129 of its ownK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- Descendant · cites it directly · 119 of its ownK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- Descendant · cites it directly · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K063345Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · cites it directly131descendants
- K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · cites it directly129descendants
- K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008 · cites it directly119descendants
- K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · cites it directly106descendants
- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 2 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −1 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| 0 (this device) | K061871 | Leica Model FL800 | Leica Microsystems, Inc. | 2006 | — |
| +1 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| +1 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| +1 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| +1 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| +2 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 15 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042961 | Spy Intra-Operative Imaging System: SP2000Summary page 1…78.4700 1. The legally marketed device to which Leica Microsystems is claiming equivalence: Novadaq SPY Intra-operative Imaging System (K042961) 2. Description of the Leica FL800: Summary: The Leica FL800 device is a surgical microscope accessory used for vi… | 2005 |
What descends from it? (133)
See all 13310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063345 | Spy Imaging System | 2007 | 131 |
| K072222 | Spy Fluorescent Imaging System | 2007 | 129 |
| K073088 | Spy Fluorescent Imaging System | 2008 | 119 |
| K091515 | Spy Scope Intra-Operative Operating System | 2009 | 106 |
| K071619 | Spy Fluorescent Imaging System | 2007 | 26 |
| K073130 | Spy Fluorescent Imaging System | 2008 | 20 |
| K080612 | Leica FL800 | 2008 | 9 |
| K100468 | Zeiss Infrared 800 with Flow 800 Option | 2010 | 4 |
| K141136 | Leica FL800 | 2014 | 3 |
| K170239 | Leica FL560 | 2017 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K063345 (Novadaq Technologies, Inc., 2007) has gone furthest, with 131 descendants of its own.
- 10 other devices also cite its predicate K042961.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Leica FL800 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061871: Leica Model FL800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061871
Report an extraction error
Are you the manufacturer?
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