510(k) K163213 ยท JAK System, X-Ray, Tomography, Computed
Revolution CT
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Dec 16, 2016 |
| Received | Nov 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | GE Medical Systems, LLC Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 Open, Classified |
JAK | None listed |
| May 8, 2026 | GE Medical Systems, LLC Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 Open, Classified |
JAK | None listed |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Apr 5, 2022 | GE Healthcare, LLC Revolution Apex, Revolution CT with Apex Edition Open, Classified |
JAK | None listed |
| Apr 5, 2022 | GE Healthcare, LLC Revolution CT, Revolution CT ES Open, Classified |
JAK | None listed |
| Nov 24, 2021 | GE Healthcare, LLC Computed Tomography Systems
Revolution CT,
Revolution CT ES,
Revolution Apex,
Revolution CT with Apex edition Open, Classified |
JAK | None listed |
| Jul 8, 2021 | GE Healthcare, LLC Revolution CT Completed |
JAK | None listed |
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system ha Open, Classified |
JAK | None listed |
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system ha Open, Classified |
JAK | None listed |
| Dec 17, 2020 | GE Healthcare, LLC System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition Terminated |
JAK | None listed |
| Dec 17, 2020 | GE Healthcare, LLC System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. Terminated |
JAK | None listed |
| Feb 6, 2019 | GE Healthcare, LLC Revolution CT systems with the SmartStep Option
The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Open, Classified |
JAK | None listed |
| Jan 19, 2019 | GE Healthcare, LLC Revolution CT scanners
Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Open, Classified |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC Revolution CT 160 1.5D STD WAUK Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.