4 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Enforcement
Class II
·Terminated·superDimension, Inc·July 18, 2012
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Recall
Terminated
·superDimension, Inc·Product code OGK·June 18, 2012
superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
FDA Recall
Terminated
·SuperDimension, Inc.·Product code JAK·November 29, 2006
Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
FDA Recall
Terminated
·SuperDimension, Inc.·Product code JAK·November 29, 2006