Flying Diagnostic Ultrasound System
FDA 510(k) K083877 · Neusoft Medical Systems Co., Ltd.
510(k) numberK083877
Submission
- Device name
- Flying Diagnostic Ultrasound System
- Applicant
- Neusoft Medical Systems Co., Ltd.
Shenyang, Liaoning, CN - Received
- December 29, 2008
- Decision date
- January 13, 2009
- 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 Flying Diagnostic Ultrasound System cleared by the FDA?
Flying Diagnostic Ultrasound System (K083877) received a 510(k) decision of Substantially Equivalent on January 13, 2009, 15 days after the submission was received.
What is the product code of K083877?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.