FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
OEC One ASD
K Number: K240828
·
Decision Dec 27, 2024
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
81
Applicant Total
12
Review Days
276
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Basic Information
- Device Name
- OEC One ASD
- K Number
- K240828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
- Date Received
- March 26, 2024
- Decision Date
- December 27, 2024
- Product Code
- OXO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | FDA class 2 | Radiology |
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|---|---|---|---|
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| K231892 | Definium Pace Select | Sep 12, 2023 | Substantially Equivalent |
| K191699 | Discovery XR656 HD with VolumeRad | Jul 24, 2019 | Substantially Equivalent |
| K182626 | OEC One | Nov 16, 2018 | Substantially Equivalent |
| K173612 | Optima XR646 HD | Dec 11, 2017 | Substantially Equivalent |
| K172700 | OEC One | Nov 9, 2017 | Substantially Equivalent |
| K172869 | Discovery XR656 HD | Oct 20, 2017 | Substantially Equivalent |
| K171800 | OEC Elite MiniView | Jul 12, 2017 | Substantially Equivalent |