NEONA 1.5T MRI System
FDA 510(k) K222259 · Time Medical Limited
510(k) numberK222259
Submission
- Device name
- NEONA 1.5T MRI System
- Applicant
- Time Medical Limited
Shatin, Hong Kong, CN - Received
- July 28, 2022
- Decision date
- February 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K183621 | EMMA 1.5T MRI SystemLNH · Abbreviated | 02/22/2019SE |
| K110942 | Pica Whole-Body MRI SystemLNH · Abbreviated | 07/26/2011SE |
| K093984 | Pica Whole Body MRI System Model TMS-MRI-3500WB-01LNH · Special | 03/24/2010SE |
| K092230 | Mona - Orthopedic MRI System, Model TMS-200ORTH-01LNH · Traditional | 11/25/2009SE |
| K091580 | Pica Whole Body MRI SystemLNH · Traditional | 07/24/2009SE |
Questions and answers
When was NEONA 1.5T MRI System cleared by the FDA?
NEONA 1.5T MRI System (K222259) received a 510(k) decision of Substantially Equivalent on February 21, 2023, 208 days after the submission was received.
What is the product code of K222259?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.