Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K121223 |
Device Name |
QLAB WITH FHN AND VPQ PLUG-IN |
Applicant |
PHILIPS ULTRASOUND, INC. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
PENNY GRECO |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/23/2012 |
Decision Date | 05/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|