510(k) K192686 ยท JAK System, X-Ray, Tomography, Computed
Revolution Maxima, Revolution Ace
| Applicant | Ge Hangwei Medical Systems Co., Ltd., Beijing Economic & Technological Develop, CN |
| Decision | Substantially Equivalent, Oct 24, 2019 |
| Received | Sep 26, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192686
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima, Model Numbers:
1) 6665000-2,
2) 6670000-2,
3) 6670000-200,
4) 6670000-6; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.