FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXL-12SP,12DP,15DP,20DP LINAC
K Number: K970137
·
Decision Apr 15, 1997
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- EXL-12SP,12DP,15DP,20DP LINAC
- K Number
- K970137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitsubishi Electronics America, Inc.
- Date Received
- January 15, 1997
- Decision Date
- April 15, 1997
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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