510(k) · Cleared
Recalled · Class II · 2013Clearstart SVM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intio, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 16, 2011 as substantially equivalent to K071310 (Siemens AG, 2007) after a 15-day review. Its family tree reaches back 7 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 20 ancestors in all, the oldest K871859 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 3 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 2 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 1 generation backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- This deviceK113541 Clearstart SVM SystemIntio, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- Descendant · 2 generations on · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK240620 Cube NavigatorMedical Templates AG · 2024
- Descendant · 3 generations on · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K141745Iqqa-Bodyimaging SoftwareEdda Technology · 2014 · cites it directly6descendants
- K191530StoneCheckerImaging Biometrics, LLC · 2019 · 2 generations on1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K240620Cube NavigatorMedical Templates AG · 2024 · 2 generations on0descendants
- K202084DeepLook PRECISEDeeplook, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −1 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| 0 (this device) | K113541 | Clearstart SVM System | Intio, Inc. | 2011 | — |
| +1 | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| +2 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +2 | K240620 | Cube Navigator | Medical Templates AG | 2024 | — |
| +3 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K071310 | Syngo CT Oncology Software PackageSummary page 1…Code: LLZ 2. Equivalent Legally Marketed Device: Manufacturer: Siemens Medical Solutions, USA, Inc. Name of Predicate Device: syngo CT Oncology FDA 510(k) Number: K071310 FDA Clearance Date: June 8, 2007. 3. Indications for Use Statement The INTIO ClearStartSVMTMI system is a self-contained ima… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141745 | Iqqa-Bodyimaging Software | 2014 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2013 | Class II | Z-0974-2013 | Labeling False and Misleading | INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K141745 (Edda Technology, 2014) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K071310.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 INTIO ClearStartSVMTM system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStartSVMTM provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images.…
Read the full statement (137 words)
The INTIO ClearStartSVMTM system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStartSVMTM provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images. Following lesion segmentation, ClearStart.SVMTM's automated volumetric, RECIST and WHO lesion measurements provide the user with data on the time-course of patient response to therapy. An on-board large disk storage capacity allows the user to easily track each patient's CT data from initial diagnosis through therapeutic interventions and follow up exams and includes a reporting package to aid in the assessment of response to therapy.
The system is password protected so that only the above mentioned trained medical professionals are authorized users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113541: Clearstart SVM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113541
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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