Acuson S2000 Ultrasound System
FDA 510(k) K072786 · Siemens Medical Solutions USA, Inc.
510(k) numberK072786
Submission
- Device name
- Acuson S2000 Ultrasound System
- Applicant
- Siemens Medical Solutions USA, Inc.
Mountain View, CA, US - Received
- October 1, 2007
- Decision date
- November 13, 2007
- 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 Acuson S2000 Ultrasound System cleared by the FDA?
Acuson S2000 Ultrasound System (K072786) received a 510(k) decision of Substantially Equivalent on November 13, 2007, 43 days after the submission was received.
What is the product code of K072786?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.