VANTAGE TITAN— 510(k) K120638
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K120638 for VANTAGE TITAN, Substantially Equivalent on 2012-06-01. 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
- Tustin, CA, US
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 K120638
K-number listed on FDA's recall record- 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.
- Z-1101-2013 — MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120638.
Data sourced from openFDA. This site is unofficial and independent of the FDA.