Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K142197 |
Device Name |
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 |
Applicant |
KONICA MINOLTA INC. |
1 SAKUA-MACHI |
HINO-SHI,
JP
191-8511
|
|
Applicant Contact |
SHIGEYUKI KOJIMA |
Correspondent |
STORCH AMINI & MUNVES PC |
140 EAST 45TH STREET, 25TH FLOOR |
NEW YORK,
NY
10017
|
|
Correspondent Contact |
RUSSEL D.MUNVES |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/11/2014 |
Decision Date | 11/21/2014 |
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
|
|
|