MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
FDA 510(k) K250443 · Siemens Healthcare GmbH
510(k) numberK250443
Submission
- Device name
- MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- Applicant
- Siemens Healthcare GmbH
Erlangen, DE - Received
- February 14, 2025
- Decision date
- June 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional | Xingaoyi Medical Equipment Co.,Ltd | 08/17/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 03/27/2026SE |
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| 510(k) | Device | Decision |
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| K253264 | myAblation Guide (VC10A)QTZ · Traditional | 06/16/2026SE |
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| K252548 | AI-Rad Companion Organs RTQKB · Traditional | 04/10/2026SE |
| K253057 | AI-Rad Companion Brain MRQIH · Traditional | 01/22/2026SE |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | 12/19/2025SE |
| K252608 | AI-Rad Companion Prostate MRLLZ · Traditional | 09/09/2025SE |
| K242551 | syngo Dynamics (Version VA41D)QIH · Traditional | 04/03/2025SE |
| K242745 | AI-Rad Companion Organs RTQKB · Traditional | 03/27/2025SE |
| K241770 | Prostate MR AI (VA10A)QDQ · Traditional | 03/05/2025SE |
| K240796 | myAblation Guide (VB80A)QTZ · Traditional | 08/06/2024SE |
Questions and answers
When was MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile cleared by the FDA?
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (K250443) received a 510(k) decision of Substantially Equivalent on June 16, 2025, 122 days after the submission was received.
What is the product code of K250443?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.