FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K Number: K072047
·
Decision Aug 29, 2007
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
3
Review Days
35
Basic Information
- Device Name
- MHI-TM2000 LINEAR ACCELERATOR SYSTEM
- K Number
- K072047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MITSUBISHI HEAVY INDUSTRIES, LTD.
- Date Received
- July 25, 2007
- Decision Date
- August 29, 2007
- 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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