Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K032681 |
Device Name |
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 |
Applicant |
KONICA MEDICAL AND GRAPHIC CORPORATION |
319 AKENO, OBATA-CHO |
WATARAI-GUN |
MIE-KEN,
JP
|
|
Applicant Contact |
SHINICHI YAMANAKA |
Correspondent |
KONICA MEDICAL AND GRAPHIC CORPORATION |
319 AKENO, OBATA-CHO |
WATARAI-GUN |
MIE-KEN,
JP
|
|
Correspondent Contact |
SHINICHI YAMANAKA |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 08/29/2003 |
Decision Date | 09/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|