FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIFS
K Number: K955583
·
Decision May 14, 1996
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
12
Review Days
161
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Basic Information
- Device Name
- VIFS
- K Number
- K955583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Konica Medical Corp.
- Date Received
- December 5, 1995
- Decision Date
- May 14, 1996
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Konica Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990969 | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | Jun 18, 1999 | Substantially Equivalent |
| K963914 | CM & CM DS-7 | Oct 8, 1997 | Substantially Equivalent |
| K963913 | MD100 & MM150 | Oct 8, 1997 | Substantially Equivalent |
| K931315 | KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR | Dec 14, 1993 | Substantially Equivalent |
| K933830 | KONICA LD-4500 LASER DIGITIZER | Dec 14, 1993 | Substantially Equivalent |
| K931317 | KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR | Dec 14, 1993 | Substantially Equivalent |
| K931316 | KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR | Dec 14, 1993 | Substantially Equivalent |
| K931313 | KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR | Sep 7, 1993 | Substantially Equivalent |
| K931314 | KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR | Sep 7, 1993 | Substantially Equivalent |
| K931312 | KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR | Sep 7, 1993 | Substantially Equivalent |