fMRI Hardware System
FDA 510(k) K191032 · Nordicneurolab AS
510(k) numberK191032
Submission
- Device name
- fMRI Hardware System
- Applicant
- Nordicneurolab AS
Bergen, NO - Received
- April 18, 2019
- Decision date
- November 27, 2019
- 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 |
| 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 |
|---|---|---|
| K251937 | nordicAudio (1.0)LNH · Traditional | 03/20/2026SE |
| K243209 | nordicMEDiVALLZ · Traditional | 10/22/2024SE |
| K241608 | nordicMEDiVALLZ · Traditional | 06/28/2024SE |
| K232680 | fMRI Hardware SystemLNH · Traditional | 12/13/2023SE |
| K212720 | nordicDSCLLZ · Traditional | 03/03/2022SE |
| K163324 | nordicBrainExLLZ · Traditional | 01/27/2017SE |
| K140956 | LCD MonitorLNH · Traditional | 08/07/2014SE |
| K133910 | NordicbrainexLLZ · Traditional | 04/04/2014SE |
| K123306 | Nordic TumorexLLZ · Traditional | 05/20/2013SE |
| K092253 | Modification to Fmri Hardware SystemLNH · Special | 10/08/2009SE |
Questions and answers
When was fMRI Hardware System cleared by the FDA?
fMRI Hardware System (K191032) received a 510(k) decision of Substantially Equivalent on November 27, 2019, 223 days after the submission was received.
What is the product code of K191032?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.