Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K203406 |
Device Name |
Lumify Diagnostic Ultrasound System |
Applicant |
Philips Ultrasound, Inc. |
22100 Bothell Everett Highway |
Bothell,
WA
98021 -8431
|
|
Applicant Contact |
Colin S. Jacob |
Correspondent |
Philips Ultrasound, Inc. |
22100 Bothell Everett Highway |
Bothell,
WA
98021 -8431
|
|
Correspondent Contact |
Colin S. Jacob |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/19/2020 |
Decision Date | 02/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|