XIDF-AWS801, Angio Workstation, V6.10— 510(k) K150967
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K150967 for XIDF-AWS801, Angio Workstation, V6.10, Substantially Equivalent on 2015-06-18. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Recent devices under product code OWB
view allMore clearances from Toshibamedical Systems Corporation
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K150967
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150967.
Data sourced from openFDA. This site is unofficial and independent of the FDA.