510(k) K101888 ยท JAK System, X-Ray, Tomography, Computed
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Apr 8, 2011 |
| Received | Jul 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101888
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Hitachi Medical Systems America Inc Hitachi Scenaria Whole-body X-ray CT System Terminated |
JAK | None listed |
| Jun 30, 2015 | Hitachi Medical Systems America Inc Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 Terminated |
JAK | None listed |
| Jul 19, 2012 | Hitachi Medical Systems America Inc Hitachi Scenaria CT System Software
Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.