Device product
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.
Z-0974-2013
Product summary
- Firm
- Intio Inc
- Event
- Event 64435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-0974-2013
Official wording
Reason: INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Code information: INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
Distribution pattern: Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Derived failure modes
-
Unknown
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.