Siemens Healthcare GmbH
FDA 510(k) & PMA Approved Devices — 31 products
Total Devices31
Categories8
Latest FDA decision2026-06-16
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253264 | myAblation Guide (VC10A) | QTZ | 2026-06-16 | View |
| 510(k) | K252548 | AI-Rad Companion Organs RT | QKB | 2026-04-10 | View |
| 510(k) | K253689 | syngo Dynamics (VA41F) | QIH | 2026-04-10 | View |
| 510(k) | K253057 | AI-Rad Companion Brain MR | QIH | 2026-01-22 | View |
| 510(k) | K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | 2025-12-19 | View |
| 510(k) | K252608 | AI-Rad Companion Prostate MR | LLZ | 2025-09-09 | View |
| 510(k) | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | LNH | 2025-06-16 | View |
| 510(k) | K242551 | syngo Dynamics (Version VA41D) | QIH | 2025-04-03 | View |
| 510(k) | K242745 | AI-Rad Companion Organs RT | QKB | 2025-03-27 | View |
| 510(k) | K241770 | Prostate MR AI (VA10A) | QDQ | 2025-03-05 | View |
| 510(k) | K240796 | myAblation Guide (VB80A) | QTZ | 2024-08-06 | View |
| 510(k) | K240294 | Syngo Carbon Enterprise Access (VA40A) | LLZ | 2024-05-23 | View |
| 510(k) | K233753 | AI-Rad Companion (Pulmonary) | JAK | 2024-03-21 | View |
| 510(k) | K232744 | syngo Virtual Cockpit (VB10A) | LLZ | 2023-12-21 | View |
| 510(k) | K232856 | Syngo Carbon Clinicals | QIH | 2023-12-01 | View |
| 510(k) | K231157 | syngo.CT Lung CAD (Version VD30) | OEB | 2023-07-19 | View |
| 510(k) | K230561 | Syngo Carbon Space VA30A | LLZ | 2023-03-21 | View |
| 510(k) | K230196 | syngo.via View&GO VA40A | LLZ | 2023-02-13 | View |
| 510(k) | K221501 | syngo.via View&GO | LLZ | 2022-10-14 | View |
| 510(k) | K213713 | AI-Rad Companion (Pulmonary) | JAK | 2022-08-11 | View |
No matching devices.
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