Aquilion One Vision, V4.90
FDA 510(k) K122109 · Toshiba America Medical Systems, In.C
510(k) numberK122109
Submission
- Device name
- Aquilion One Vision, V4.90
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- July 17, 2012
- Decision date
- September 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aquilion One Vision, V4.90 cleared by the FDA?
Aquilion One Vision, V4.90 (K122109) received a 510(k) decision of Substantially Equivalent on September 21, 2012, 66 days after the submission was received.
What is the product code of K122109?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.