FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ACCULEAF
K Number: K040553
·
Decision Apr 1, 2004
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
22
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO ACCULEAF
- K Number
- K040553
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Direx Systems Corp.
- Date Received
- March 2, 2004
- Decision Date
- April 1, 2004
- 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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