Magnifico Open (100009900)
FDA 510(k) K251901 · Esaote, S.p.A.
510(k) numberK251901
Submission
- Device name
- Magnifico Open (100009900)
- Applicant
- Esaote, S.p.A.
Genoa, IT - Received
- June 20, 2025
- Decision date
- March 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Canon Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K261331 | I-Genius (100019400)LNH · Traditional | 07/31/2026SE |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | 03/27/2026SE |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN · Special | 11/25/2025SE |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN · Traditional | 06/18/2025SE |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | 05/16/2025SE |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH · Special | 06/26/2024SE |
| K230179 | 6440 MyLabX90IYN · Traditional | 11/29/2023SE |
| K212419 | Magnifico Open, Magnifico MSKLNH · Traditional | 02/04/2022SE |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75IYN · Traditional | 09/16/2021SE |
Questions and answers
When was Magnifico Open (100009900) cleared by the FDA?
Magnifico Open (100009900) (K251901) received a 510(k) decision of Substantially Equivalent on March 5, 2026, 258 days after the submission was received.
What is the product code of K251901?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.