FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KONICA KFDR-S
K Number: K896739
·
Decision Apr 30, 1990
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
12
Review Days
151
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Basic Information
- Device Name
- KONICA KFDR-S
- K Number
- K896739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Konica Medical Corp.
- Date Received
- November 30, 1989
- Decision Date
- April 30, 1990
- Product Code
- LMA
- 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMA), ordered by most recent decision date.
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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 |
| K955583 | VIFS | May 14, 1996 | 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 |