510(k) K213715 ยท JAK System, X-Ray, Tomography, Computed
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Dec 17, 2021 |
| Received | Nov 24, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213715
| 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 Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 Open, Classified |
JAK | None listed |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 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 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 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 Apex Elite, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Select, 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.