Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K212333 |
Device Name |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 |
Applicant |
Canon Medical Systems Corporation |
1385 Shimoishigami |
Otawara-shi,
JP
324-8550
|
|
Applicant Contact |
Paul Biggins |
Correspondent |
Canon Medical Systems USA, Inc. |
2441 Michelle Drive |
Tustin,
CA
92780
|
|
Correspondent Contact |
Yoshiaki Cook |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/27/2021 |
Decision Date | 01/24/2022 |
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
|
|
|