FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
BREAST-BOARD (MULTIPLE)
K Number: K003778
·
Decision Jun 8, 2001
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
9
Review Days
183
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Basic Information
- Device Name
- BREAST-BOARD (MULTIPLE)
- K Number
- K003778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arplay Medical S.A.
- Date Received
- December 7, 2000
- Decision Date
- June 8, 2001
- 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 Arplay Medical S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K010065 | CRANIAL STEREOTACTIC EQUIPMENT | Jul 2, 2002 | Substantially Equivalent |
| K004023 | INTRA OPERATIVE RADIATION THERAPY | Sep 21, 2001 | Substantially Equivalent |
| K003779 | IMMOBILIZATION SYSTEM FOR ENT | Jul 12, 2001 | Substantially Equivalent |
| K010172 | LEAD BLOCKS | Apr 18, 2001 | Substantially Equivalent |
| K010174 | TRAY ADAPTERS, MULTIPLE | Apr 18, 2001 | Substantially Equivalent |
| K010063 | COUCH FOR TOTAL BODY RADIATION | Apr 2, 2001 | Substantially Equivalent |
| K010062 | STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K004015 | BEAM BLOCK TRAYS | Mar 13, 2001 | Substantially Equivalent |