Devices

Device Recall INTIO Inc. ClearStartSVM

Model / Serial
INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Product Description
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
Manufacturer
Intio Inc
1 Event
- Recall of Device Recall INTIO Inc. ClearStartSVM

Manufacturer

Intio Inc

Manufacturer Address
Intio Inc, 325 Interlocken Pkwy, Broomfield CO 80021-3497
Manufacturer Parent Company (2017)
Intio Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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