510(k) K161201 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
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| Applicant | Riverain Technologies, LLC, Miamisburg OH, US |
| Decision | Substantially Equivalent, Sep 9, 2016 |
| Received | Apr 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161201
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.