Recall Z-0974-2013— Intio Inc
Class II · Terminated
Class II FDA medical device recall by Intio Inc, initiated 2013-02-26, terminated 2013-04-17. It names one FDA 510(k) clearance: K113541. 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.. Reason: INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use..
- Recalling firm
- Intio Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-26
- Terminated
- 2013-04-17
- Firm location
- Broomfield, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.