510(k) K180901 ยท JAK System, X-Ray, Tomography, Computed
Low Dose CT Lung Cancer Screening Option
| Applicant | Hitachi Healthcare Americas, Twinsburg OH, US |
| Decision | Substantially Equivalent, May 16, 2018 |
| Received | Apr 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180901
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.