FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K Number: K990969
·
Decision Jun 18, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
12
Review Days
87
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Basic Information
- Device Name
- KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
- K Number
- K990969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Konica Medical Corp.
- Date Received
- March 23, 1999
- Decision Date
- June 18, 1999
- Product Code
- IXW
- 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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | FDA class 2 | Radiology |
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Other Clearances by Konica Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K931312 | KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR | Sep 7, 1993 | Substantially Equivalent |