Hitachi Healthcare Americas - FDA 510(k) Cleared Devices
Recent clearances: OASIS MRI System, Arietta 65, OASIS MRI System
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hitachi Healthcare Americas Radiology ✕
11 devices
Cleared
Oct 07, 2021
OASIS MRI System
Radiology
154d
Cleared
Nov 04, 2020
Arietta 65
Radiology
72d
Cleared
Oct 21, 2020
OASIS MRI System
Radiology
91d
Cleared
Jul 17, 2020
SCENARIA View
Radiology
140d
Cleared
Feb 21, 2020
OASIS MRI System
Radiology
141d
Cleared
Sep 13, 2019
SCENARIA View
Radiology
165d
Cleared
Aug 09, 2019
ARIETTA 750
Radiology
93d
Cleared
Apr 02, 2019
ARIETTA 50
Radiology
54d
Cleared
Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
Radiology
67d
Cleared
Jan 28, 2019
Aloka Arietta 850
Radiology
46d
Cleared
May 16, 2018
Low Dose CT Lung Cancer Screening Option
Radiology
40d