510(k) K151833 ยท JAK System, X-Ray, Tomography, Computed
Aquilion Lightning (TSX-035A/2, V7.0)
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Oct 9, 2015 |
| Received | Jul 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2016 | Toshiba American Medical Systems Inc Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03
Product Usage:
Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.