Hitachi Healthcare Americas is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hitachi Healthcare Americas - FDA 510(k) Cleared Devices
Recent clearances: OASIS MRI System, Arietta 65, OASIS MRI System
12
Total
12
Cleared
0
Denied
Hitachi Healthcare Americas has 12 FDA 510(k) cleared radiology devices. Based in Twinsburg, US.
Last cleared in 2021. Active since 2018.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by FUJIFILM Healthcare Americas Corporation as regulatory consultant.
FDA 510(k) Regulatory Record - Hitachi Healthcare Americas
12 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
Aug 17, 2018
Optical Topography System ETG-4100
Neurology
365d
Cleared
May 16, 2018
Low Dose CT Lung Cancer Screening Option
Radiology
40d