FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEREOTACTIC IRRADIATION SYSTEM
K Number: K904908
·
Decision Jun 6, 1991
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
218
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Basic Information
- Device Name
- STEREOTACTIC IRRADIATION SYSTEM
- K Number
- K904908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Northwest Medical Physics Center
- Date Received
- October 31, 1990
- Decision Date
- June 6, 1991
- 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 Northwest Medical Physics Center
| K Number | Device Name | ||
|---|---|---|---|
| K953227 | CASPER | Nov 22, 1995 | Substantially Equivalent |
| K941118 | HEAD IMMOBILIZATION APPARATUS | Aug 25, 1995 | Substantially Equivalent |
| K933117 | IORT SYSTEM | Feb 16, 1995 | Substantially Equivalent |
| K944613 | SHOULDER RETRACTOR | Jan 18, 1995 | Substantially Equivalent |
| K930182 | RADIATION TREATMENT FOR CANCER PATIENTS | Jan 5, 1994 | Substantially Equivalent |