OEC Elite
FDA 510(k) K171565 · Ge Oec Medical Systems, Inc.
510(k) numberK171565
Submission
- Device name
- OEC Elite
- Applicant
- Ge Oec Medical Systems, Inc.
Salt Lake City, UT, US - Received
- May 30, 2017
- Decision date
- August 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Genoray Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233669 | Oec 3DOXO · Traditional | 03/28/2024SE |
| K203346 | Oec 3DOXO · Traditional | 03/05/2021SE |
| K192819 | OEC EliteOXO · Special | 11/08/2019SE |
| K172550 | OEC EliteOXO · Traditional | 11/16/2017SE |
| K132027 | Oec 9800 PlusOWB · Special | 05/01/2014SE |
| K111551 | Oec(R) 9800, Oec(R) 9800 PlusOWB · Traditional | 10/04/2011SE |
| K073543 | Oec 9900 EliteOWB · Traditional | 05/02/2008SE |
| K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsOWB · Traditional | 08/15/2006SE |
| K052039 | GE Oec AltitudeIZI · Abbreviated | 08/11/2005SE |
| K051490 | GE Oec Everview 7500OXO · Traditional | 07/07/2005SE |
Questions and answers
When was OEC Elite cleared by the FDA?
OEC Elite (K171565) received a 510(k) decision of Substantially Equivalent on August 10, 2017, 72 days after the submission was received.
What is the product code of K171565?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.