Vantage Titan 3T, MRT-3010/A7, M-Power GX
FDA 510(k) K172878 · Toshiba Medical Systems Corporation, Japan
510(k) numberK172878
Submission
- Device name
- Vantage Titan 3T, MRT-3010/A7, M-Power GX
- Applicant
- Toshiba Medical Systems Corporation, Japan
Otawara-Shi, JP - Received
- September 21, 2017
- Decision date
- November 17, 2017
- 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 Titan 3T, MRT-3010/A7, M-Power GX cleared by the FDA?
Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878) received a 510(k) decision of Substantially Equivalent on November 17, 2017, 57 days after the submission was received.
What is the product code of K172878?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.