510(k) · Cleared
ClearedVisualase Envision Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotex, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 12, 2006 as substantially equivalent to K960265 (GE Medical Systems, 1996) after a 22-day review. Its family tree reaches back 2 generations to 1991. 2 of the 31 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.
- Decided
- Dec 12, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913475 (1991). 3 ancestors in all. 27 later devices descend from it, 1 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 1 generation backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- This deviceK063505 Visualase Envision Software SystemBiotex, Inc. · 2006
- Descendant · cites it directly · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · 3 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · cites it directly26descendants
- K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 2 generations on22descendants
- K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on21descendants
- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
- K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −1 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| 0 (this device) | K063505 | Visualase Envision Software System | Biotex, Inc. | 2006 | — |
| +1 | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | 1 |
| +2 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +3 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +4 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +4 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 4 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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.
2 devices in this family have a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…Predicate Device GE Medical Systems: Advantage Windows Workstation with FuncTool option (K960265). Description of Device The Visualase ENVISION platform consists of a PC-based Linux workstation running t… | 1996 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071328 | Visualase Thermal Therapy System | 2007 | 26 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K071328 (Biotex, Inc., 2007) has gone furthest, with 26 descendants of its own.
- 12 other devices also cite its predicate K960265.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase…
Read the full statement (148 words)
The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063505: Visualase Envision Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063505
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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