510(k) · Cleared
ClearedViz CTP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 20, 2018 as substantially equivalent to K121447 (Ischemaview, Inc., 2013) after a 91-day review. Its family tree reaches back 11 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 20, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K896095 (1990). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 2 generations backK120196 Olea SphereOlea Medical · 2012
- 1 generation backK121447 Ischema View RapidIschemaview, Inc. · 2013
- This deviceK180161 Viz CTPViz. Ai, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK221627 PerfusionGo PlusYukun (Beijing) Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK192962 icobrain-ctpIcometrix NV · 2020
Show all 11 generations
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 9 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 8 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 7 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 6 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 5 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 4 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 3 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 2 generations backK120196 Olea SphereOlea Medical · 2012
- 1 generation backK121447 Ischema View RapidIschemaview, Inc. · 2013
- This deviceK180161 Viz CTPViz. Ai, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −10 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −9 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −8 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −7 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −6 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −5 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −4 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −3 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −2 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −1 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| 0 (this device) | K180161 | Viz CTP | Viz. Ai, Inc. | 2018 | — |
| +1 | K221627 | PerfusionGo Plus | Yukun (Beijing) Technology Co., Ltd. | 2023 | — |
| +1 | K192962 | icobrain-ctp | Icometrix NV | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K121447 | Ischema View RapidSummary page 4…n No: 21 C.F.R. § 892.2050 Regulatory Class: Class II Product Code: LLZ Predicate Devices iSchemaView Inc.’s RAPID (K121447) Device Description Viz CTP is a standalone software package that is comprised of several modules including DICOM rec… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K221627 (Yukun (Beijing) Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K121447.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Viz CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices. Viz CTP…
Read the full statement (133 words)
Viz CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
Viz CTP provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180161 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180161: Viz CTP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180161
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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