FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
K Number: K872245
·
Decision Jun 19, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
17
Applicant Total
254
Review Days
8
Basic Information
- Device Name
- PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
- K Number
- K872245
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1890
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- GENERAL ELECTRIC CO.
- Date Received
- June 11, 1987
- Decision Date
- June 19, 1987
- 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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