FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
K Number: K931002
·
Decision Jun 8, 1993
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
13
Applicant Total
70
Review Days
102
Basic Information
- Device Name
- FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
- K Number
- K931002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1630
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- Date Received
- February 26, 1993
- Decision Date
- June 8, 1993
- Product Code
- IXK
- 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 |
|---|---|---|---|
| IXK | System, Imaging, X-Ray, Electrostatic | FDA class 2 | Radiology |
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