Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k) K253625 · Canon Medical Systems Corporation
510(k) numberK253625
Submission
- Device name
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- November 18, 2025
- Decision date
- March 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR cleared by the FDA?
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 129 days after the submission was received.
What is the product code of K253625?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.