510(k) K062315 ยท JAK System, X-Ray, Tomography, Computed
SUPERDIMENSION/BRONCHUS PREMIUM 2
| Applicant | Superdimension, Ltd., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2006 |
| Received | Aug 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.