510(k) · Cleared
ClearedCONVIVO In Vivo Pathology Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · LLZ System, Image Processing, Radiological
Cleared on Dec 29, 2021 as substantially equivalent to K181116 (Carl Zeiss Meditec, AG, 2018) after a 254-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 29, 2021
- Review
- 254 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002788 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000 · Recalled
- 3 generations backK161112 KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016
- 2 generations backK180270 Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
- 1 generation backK181116 ConvivoCarl Zeiss Meditec, AG · 2018
- This deviceK211156 CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002788 | Ksea Neuro-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 2000 | 4 |
| −3 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016 | — |
| −2 | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2018 | — |
| −1 | K181116 | Convivo | Carl Zeiss Meditec, AG | 2018 | — |
| 0 (this device) | K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021 | — |
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? (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.
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 21 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 4 ancestors has 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. 2021, 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 CONVIVO In Vivo Pathology Suite is a system that contains a surgical endo-microscope and a cloud software module. The Suite allows for real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology). The device is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation. CONVIVO Surgical Workplace is a…
Read the full statement (130 words)
The CONVIVO In Vivo Pathology Suite is a system that contains a surgical endo-microscope and a cloud software module. The Suite allows for real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology). The device is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation.
CONVIVO Surgical Workplace is a surgical endo-microscope that acquires data and creates in-vivo images and image sequences of tissue microstructure. CONVIVO’s fiber optic scanner probe is placed in direct contact with tissue during cranial procedures to create in-vivo confocal laser scanning images of the internal microstructure of tissues.
CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO Surgical Workplace).
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/K211156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211156: CONVIVO In Vivo Pathology Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211156
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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