FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXL-22DP X-RAY RADIATION THERAPY SYSTEM
K Number: K873398
·
Decision Apr 29, 1988
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
5
Review Days
249
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Basic Information
- Device Name
- EXL-22DP X-RAY RADIATION THERAPY SYSTEM
- K Number
- K873398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Mitsubishi Intl. Corp.
- Date Received
- August 24, 1987
- Decision Date
- April 29, 1988
- 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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Other Clearances by Mitsubishi Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961214 | MULTI LEAF COLLIMATOR | Aug 6, 1996 | Substantially Equivalent |
| K952314 | EXL-12SP & 12DP LINAC | Jan 17, 1996 | Substantially Equivalent |
| K952108 | EXL-15DP & 20-DP LINAC | Dec 21, 1995 | Substantially Equivalent |
| K880200 | EXL-14 MEDICAL LINEAR ACCELERATOR | Aug 4, 1988 | Substantially Equivalent |