4 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Enforcement
Class II
·Terminated·Intio Inc·March 27, 2013
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.
FDA Recall
Terminated
·Intio Inc·Product code LLZ·February 26, 2013
MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.
FDA Recall
Terminated
·Miramar Labs, Inc.·Product code OUB·April 24, 2011
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
FDA Enforcement
Class II
·Terminated·ZYTO Technologies, Inc.·July 13, 2016