Beyondimage Workstation
FDA 510(k) K102435 · Neusoft Medical Systems Co., Ltd.
510(k) numberK102435
Submission
- Device name
- Beyondimage Workstation
- Applicant
- Neusoft Medical Systems Co., Ltd.
Shenyang, Liaoning, CN - Received
- August 26, 2010
- Decision date
- October 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Beyondimage Workstation cleared by the FDA?
Beyondimage Workstation (K102435) received a 510(k) decision of Substantially Equivalent on October 15, 2010, 50 days after the submission was received.
What is the product code of K102435?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.