FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VOXBOX
K Number: K954199
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
17
Applicant Total
3
Review Days
23
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Basic Information
- Device Name
- VOXBOX
- K Number
- K954199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1890
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voxel
- Date Received
- September 6, 1995
- Decision Date
- September 29, 1995
- Product Code
- IXC
- 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 |
|---|---|---|---|
| IXC | Illuminator, Radiographic-Film | FDA class 1 | Radiology |
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