ClearStart SVM System
by Intio, Inc.
510(k) K113541
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113541 | Date16 Dec 2011 | StatusActive |
Recalls
-
- Terminated 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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ClearStart SVM System is a semi-automated medical imaging device designed for segmenting and measuring tumors in the liver, lung, and lymph nodes. It integrates image processing and display software to provide both multiplanar reconstruction (MPR) 2D imaging and 3D volume-rendered (VR) visualization, aiding radiologic assessment and diagnostic workflows.
This system is intended for use in radiology settings and has received FDA 510(k) clearance under K113541, classified as a Class II X-ray system. It is supplied as a complete software-hardware solution, with no explicit indication of sterility or single-use/reusability in the regulatory data. The device operates within standard MRI safety guidelines for non-MRI environments, and no specific storage conditions are detailed beyond typical medical imaging equipment requirements.
Questions
AI-generated answers, 19 Sep 2026
What types of tumors and anatomical regions can the ClearStart SVM System analyze, and how does it assist radiologists in their workflow?
The ClearStart SVM System is specifically designed to segment and measure tumors in the liver, lung, and lymph nodes. It integrates image processing and display software to provide both multiplanar reconstruction (MPR) 2D imaging and 3D volume-rendered (VR) visualization. This aids radiologists by streamlining the diagnostic workflow, allowing for more precise tumor assessment and measurement in these key anatomical regions.
Is the ClearStart SVM System intended for use in MRI environments, or is it meant for non-MRI settings?
The ClearStart SVM System is explicitly designed for use in non-MRI environments, adhering to standard MRI safety guidelines for such settings. It is not intended for use inside MRI rooms or environments where MRI systems are operational.
How is the ClearStart SVM System supplied, and does it include both hardware and software components?
The ClearStart SVM System is supplied as a complete software-hardware solution, meaning it includes both the necessary hardware and integrated imaging software required for tumor segmentation, measurement, and visualization. No additional components are required for basic operation.
Are there any specific storage requirements for the ClearStart SVM System beyond standard medical imaging equipment guidelines?
The regulatory data does not specify any unique storage conditions beyond those typically required for medical imaging equipment. Users should follow standard practices for maintaining optimal performance, such as protecting against physical damage, temperature fluctuations, and environmental contaminants.
Is the ClearStart SVM System reusable or single-use, and is it sterile?
The regulatory data does not explicitly state whether the ClearStart SVM System is single-use or reusable, nor does it mention sterility. Since it is a semi-automated imaging device (not a consumable or disposable), it is likely intended for repeated use in clinical settings, though users should follow manufacturer guidelines for cleaning, maintenance, and infection control.