MRT-50A Mobile
FDA 510(k) K893750 · Toshiba Medical Systems
510(k) numberK893750
Submission
- Device name
- MRT-50A Mobile
- Applicant
- Toshiba Medical Systems
Tustin, CA, US - Received
- May 18, 1989
- Decision date
- August 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K960948 | Scatter Correction Volume Software Model NSSC-020AKPS · Traditional | 12/23/1996SE |
| K954310 | BLA-800AKPW · Traditional | 10/18/1995SE |
| K954309 | AngiorexIZI · Traditional | 10/06/1995SE |
| K891453 | Diagnostic Ultrasound Transducer: PVE-582VIYO · Traditional | 06/01/1989SE |
| K890969 | Transesophageal Transducer PEF-511SAIYO · Traditional | 05/16/1989SE |
| K884788 | Toshiba TCT-600XT Computed Tomography X-Ray SystemJAK · Traditional | 02/27/1989SE |
| K884555 | TCT-600HQ Compu Tomo(Ct)Xray/Head/Whole Body ExamJAK · Traditional | 02/27/1989SE |
| K883359 | Diagnostic Ultrasound System SSA-270AIYO · Traditional | 01/25/1989SE |
| K883756 | Toshiba MRT-50A Magnetic Resonance SystemLNH · Traditional | 11/14/1988SE |
| K881305 | TCT-300S Computed Tomo. (CT) X-Ray System for ExamJAK · Traditional | 10/19/1988SE |
Questions and answers
When was MRT-50A Mobile cleared by the FDA?
MRT-50A Mobile (K893750) received a 510(k) decision of Substantially Equivalent on August 9, 1989, 83 days after the submission was received.
What is the product code of K893750?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.