# K113541: Clearstart SVM System

- Pathway: 510(k) (Traditional)
- Applicant: Intio, Inc.
- Decided: Dec 16, 2011 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 20 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) Summary page 1.

## Most influential descendants
- K141745: Iqqa-Bodyimaging Software (2014), 6 descendants of its own
- K191530: StoneChecker (2019), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K240620: Cube Navigator (2024), 0 descendants of its own
- K202084: DeepLook PRECISE (2021), 0 descendants of its own

## Recalls of this device
- Feb 26, 2013 · Class II · Z-0974-2013: INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.

## Indications for use
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.

Source page: https://510kreport.com/device/K113541
Methodology: https://510kreport.com/methodology