Brivo MR355, Optima MR360
FDA 510(k) K103330 · Ge Hangwei Medical Systems Co., Ltd.
510(k) numberK103330
Submission
- Device name
- Brivo MR355, Optima MR360
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN - Received
- November 12, 2010
- Decision date
- February 11, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Brivo MR355, Optima MR360 cleared by the FDA?
Brivo MR355, Optima MR360 (K103330) received a 510(k) decision of Substantially Equivalent on February 11, 2011, 91 days after the submission was received.
What is the product code of K103330?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.