XIDF-AWS801, ANGIO WORKSTATION, V5.31— 510(k) K141541

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K141541 for XIDF-AWS801, ANGIO WORKSTATION, V5.31, Substantially Equivalent on 2014-09-08. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant
Toshibamedical Systems Corporation
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tustin, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.