FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIMA XR120
K Number: K111304
·
Decision Jul 19, 2011
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
104
Review Days
71
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Basic Information
- Device Name
- OPTIMA XR120
- K Number
- K111304
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1670
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems, LLC
- Date Received
- May 9, 2011
- Decision Date
- July 19, 2011
- Product Code
- IXL
- 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 |
|---|---|---|---|
| IXL | Device, Spot-Film | FDA class 2 | Radiology |
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