Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K032924 |
Device Name |
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 |
Applicant |
VOLUME INTERACTIONS PTE LTD |
5 SHENTON WAY |
#37-04 UIC BUILDING |
SINGAPORE,
SG
|
|
Applicant Contact |
JOHN BABY |
Correspondent |
VOLUME INTERACTIONS PTE LTD |
5 SHENTON WAY |
#37-04 UIC BUILDING |
SINGAPORE,
SG
|
|
Correspondent Contact |
JOHN BABY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 10/10/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|