Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K142779 |
Device Name |
SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED |
Applicant |
SIMPLEWARE LTD. |
BRADNINCH HALL, CASTLE STREET |
EXETER,
GB
EX43PL
|
|
Applicant Contact |
GARETH JAMES |
Correspondent |
SIMPLEWARE LTD. |
BRADNINCH HALL, CASTLE STREET |
EXETER,
GB
EX43PL
|
|
Correspondent Contact |
GARETH JAMES |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/26/2014 |
Decision Date | 04/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|