Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K141561 |
Device Name |
VM PACS WITH VM MEDICAL WORKSTATION |
Applicant |
VISUAL MEDICA |
ECUADOR 1465 1 D |
CIUDAD AUTONOMA DE BUENOS AIRES,
AR
CP 1425
|
|
Applicant Contact |
MELISSA LLABRES GRAU |
Correspondent |
VISUAL MEDICA |
ECUADOR 1465 1 D |
CIUDAD AUTONOMA DE BUENOS AIRES,
AR
CP 1425
|
|
Correspondent Contact |
MELISSA LLABRES GRAU |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/12/2014 |
Decision Date | 01/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|