510(k) K181403 ยท OWB Interventional Fluoroscopic X-Ray System
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | May 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 5, computed tomography x-ray system Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
| Jun 15, 2021 | GE Healthcare, LLC GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125 Terminated |
OWB | None listed |
| Mar 15, 2019 | GE Healthcare, LLC Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention Open, Classified |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.