FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KONICA LASER IMAGER, DRYPRO MODEL 722
K Number: K992586
·
Decision Oct 29, 1999
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
120
Applicant Total
5
Review Days
88
Basic Information
- Device Name
- KONICA LASER IMAGER, DRYPRO MODEL 722
- K Number
- K992586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- KONICA CORP.
- Date Received
- August 2, 1999
- Decision Date
- October 29, 1999
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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Other Clearances by KONICA CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K990359 | KONICA DIRECT DIGITIZER, MODEL DD-341 | Aug 17, 1999 | Substantially Equivalent |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Jun 19, 1998 | Substantially Equivalent |
| K920769 | KONICA LI 10 AND 10A LASER IMAGER | May 6, 1992 | Substantially Equivalent |
| K920558 | KONICA DIRECT DIGITIZER KD-1000 | Mar 6, 1992 | Substantially Equivalent |