510(k) K052260 ยท JAK System, X-Ray, Tomography, Computed
SUPERDIMENSION/BRONCHUS 4.1
| Applicant | Superdimension, Ltd., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | Aug 19, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2012 | superDimension, Inc 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 Terminated |
OGK | None listed |
| Mar 29, 2007 | SuperDimension, Inc. superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.