XIDF-AWS801, Angio Workstation, v5.31
FDA 510(k) K142736 · Toshibamedical Systems Corporation
510(k) numberK142736
Submission
- Device name
- XIDF-AWS801, Angio Workstation, v5.31
- Applicant
- Toshibamedical Systems Corporation
Otawara-Shi, JP - Received
- September 23, 2014
- Decision date
- March 11, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was XIDF-AWS801, Angio Workstation, v5.31 cleared by the FDA?
XIDF-AWS801, Angio Workstation, v5.31 (K142736) received a 510(k) decision of Substantially Equivalent on March 11, 2015, 169 days after the submission was received.
What is the product code of K142736?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.