SIGNA Sprint
FDA 510(k) K251399 · Ge Medical Systems, LLC
510(k) numberK251399
Submission
- Device name
- SIGNA Sprint
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- May 6, 2025
- Decision date
- September 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K253808 | AIR Recon DLLNH · Traditional | 08/13/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | 06/24/2026SE |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH · Traditional | 04/14/2026SE |
| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | 03/20/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | 02/05/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
| K250941 | Revolution VibeJAK · Traditional | 08/01/2025SE |
| K243667 | Sonic DLLNH · Traditional | 06/05/2025SE |
| K250379 | SIGNA Prime EliteLNH · Traditional | 03/17/2025SE |
Questions and answers
When was SIGNA Sprint cleared by the FDA?
SIGNA Sprint (K251399) received a 510(k) decision of Substantially Equivalent on September 11, 2025, 128 days after the submission was received.
What is the product code of K251399?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.