FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASPER
K Number: K953227
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
6
Review Days
140
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Basic Information
- Device Name
- CASPER
- K Number
- K953227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Northwest Medical Physics Center
- Date Received
- July 5, 1995
- Decision Date
- November 22, 1995
- Product Code
- IXI
- 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 |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Northwest Medical Physics Center
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K904908 | STEREOTACTIC IRRADIATION SYSTEM | Jun 6, 1991 | Substantially Equivalent |