FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Optima XR646
K Number: K143270
·
Decision Feb 18, 2015
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
12
Review Days
97
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Basic Information
- Device Name
- Optima XR646
- K Number
- K143270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
- Date Received
- November 13, 2014
- Decision Date
- February 18, 2015
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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