Vantage Titan 3T
FDA 510(k) K102489 · Toshiba Medical Systems Corporation, Japan
510(k) numberK102489
Submission
- Device name
- Vantage Titan 3T
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- August 31, 2010
- Decision date
- August 2, 2011
- 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 |
|---|---|---|
| K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GXLNH · Traditional | 11/17/2017SE |
| K133324 | Suresubtraction LungJAK · Traditional | 09/05/2014SE |
| K121911 | Octave Speeder SpineMOS · Special | 08/17/2012SE |
| K121910 | Octave Speeder HeadMOS · Special | 08/17/2012SE |
| K121577 | Aplio Artida Diagnostic Ultrasound SystemIYN · Special | 06/22/2012SE |
| K120546 | Aquilion PremiumJAK · Special | 06/13/2012SE |
| K112054 | Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000VJAA · Special | 08/05/2011SE |
| K103645 | Aplio XG Diagnostic Ultrasound SystemITX · Special | 01/12/2011SE |
Questions and answers
When was Vantage Titan 3T cleared by the FDA?
Vantage Titan 3T (K102489) received a 510(k) decision of Substantially Equivalent on August 2, 2011, 336 days after the submission was received.
What is the product code of K102489?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.