510(k) K232344 ยท OWB Interventional Fluoroscopic X-Ray System
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Oct 11, 2023 |
| Received | Aug 4, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 3 Pulse angiographic X-ray system Open, Classified |
OWB | None listed |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 5 Pulse angiographic X-ray system Open, Classified |
OWB | None listed |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 7 Pulse angiographic X-ray system Open, Classified |
OWB | None listed |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS Pulse angiographic X-ray system Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.