FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
K Number: K854486
·
Decision Jan 10, 1986
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
76
Applicant Total
3
Review Days
64
Basic Information
- Device Name
- TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
- K Number
- K854486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- ABSOLUTE X-RAY CORP.
- Date Received
- November 7, 1985
- Decision Date
- January 10, 1986
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
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