V5MS Transducer
FDA 510(k) K121807 · Siemens Medical Solutions USA, Inc.
510(k) numberK121807
Submission
- Device name
- V5MS Transducer
- Applicant
- Siemens Medical Solutions USA, Inc.
Moutain View, CA, US - Received
- June 20, 2012
- Decision date
- July 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was V5MS Transducer cleared by the FDA?
V5MS Transducer (K121807) received a 510(k) decision of Substantially Equivalent on July 10, 2012, 20 days after the submission was received.
What is the product code of K121807?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.