SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
FDA 510(k) K142395 · Siemens Medical Solutions USA, Inc.
510(k) numberK142395
Submission
- Device name
- SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
- Applicant
- Siemens Medical Solutions USA, Inc.
Moutain View, CA, US - Received
- August 27, 2014
- Decision date
- September 9, 2014
- 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 SC2000 and ACUSON X300 Diagnostic Ultrasound Systems cleared by the FDA?
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems (K142395) received a 510(k) decision of Substantially Equivalent on September 9, 2014, 13 days after the submission was received.
What is the product code of K142395?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.