OEC Elite MiniView
FDA 510(k) K160131 · Ge Hangwei Medical Systems Co., Ltd.
510(k) numberK160131
Submission
- Device name
- OEC Elite MiniView
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN - Received
- January 20, 2016
- Decision date
- June 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243452 | Orthoscan VERSA Mini C-ArmOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2025SE |
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Questions and answers
When was OEC Elite MiniView cleared by the FDA?
OEC Elite MiniView (K160131) received a 510(k) decision of Substantially Equivalent on June 21, 2016, 153 days after the submission was received.
What is the product code of K160131?
The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.