Vantage Titan 1.5T, MRT-1510, M-Power GX— 510(k) K170412
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K170412 for Vantage Titan 1.5T, MRT-1510, M-Power GX, Substantially Equivalent on 2017-06-07. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Recent devices under product code LNH
view allMore clearances from Toshibamedical Systems Corporation
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170412
K-number listed on FDA's recall record- Z-2045-2021 — Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
- Z-0199-2019 — Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170412.
Data sourced from openFDA. This site is unofficial and independent of the FDA.