FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTX 1824 SPOTFILM DEVICE
K Number: K950317
·
Decision Feb 8, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
169
Review Days
13
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Basic Information
- Device Name
- ADVANTX 1824 SPOTFILM DEVICE
- K Number
- K950317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1670
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems
- Date Received
- January 26, 1995
- Decision Date
- February 8, 1995
- Product Code
- IXL
- 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 |
|---|---|---|---|
| IXL | Device, Spot-Film | FDA class 2 | Radiology |
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