uMR Astra
FDA 510(k) K260113 · Shanghai United Imaging Healthcare Co., Ltd.
510(k) numberK260113
Submission
- Device name
- uMR Astra
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN - Received
- January 14, 2026
- Decision date
- May 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LNH
| 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 |
| 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 |
| K251937 | nordicAudio (1.0)LNH · Traditional | Nordicneurolab AS | 03/20/2026SE |
More from Nordicneurolab AS
| 510(k) | Device | Decision |
|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | 08/21/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | 07/28/2026SE |
| K253077 | uOmnispace.MRQIH · Traditional | 04/22/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | 02/13/2026SE |
| K253173 | uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | 11/26/2025SE |
| K252371 | uMR 680LNH · Special | 09/25/2025SE |
| K250045 | uWS-Angio ProLLZ · Traditional | 09/24/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | 09/19/2025SE |
Questions and answers
When was uMR Astra cleared by the FDA?
uMR Astra (K260113) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 128 days after the submission was received.
What is the product code of K260113?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.