Ultraextend USWS-900A V2.1 and V3.1
FDA 510(k) K131822 · Toshiba America Medical Systems, In.C
510(k) numberK131822
Submission
- Device name
- Ultraextend USWS-900A V2.1 and V3.1
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- June 20, 2013
- Decision date
- July 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Ultraextend USWS-900A V2.1 and V3.1 cleared by the FDA?
Ultraextend USWS-900A V2.1 and V3.1 (K131822) received a 510(k) decision of Substantially Equivalent on July 23, 2013, 33 days after the submission was received.
What is the product code of K131822?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.