Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K233698 |
Device Name |
True Enhance DL |
Applicant |
GE Healthcare Japan Corporation |
7-127, Asahigaoka, 4-chome |
Hino-shi,
JP
191-8503
|
|
Applicant Contact |
Laura Turner |
Correspondent |
GE Healthcare Japan Corporation |
7-127, Asahigaoka, 4-chome |
Hino-shi,
JP
191-8503
|
|
Correspondent Contact |
Laura Turner |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/17/2023 |
Decision Date | 04/11/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|