# Hitachi Healthcare Americas

- Location (FDA's records): Twinsburg, OH
- FDA decisions: 17 (2017–2021): 17 510(k) clearances
- Names in FDA's records: Hitachi Healthcare Americas (12); Hitachi Healthcare Americas Corporation (5)
- Product codes: IYN (7), JAK (5), LNH (4), DQA (1)
- 510(k) review time since 2016: median 91 days, against 94 for FDA's reviews in the same codes and years (8 of 17 faster)
- Predicates its devices cite: 18 (11 its own); citations of its devices by later devices: 16 (11 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hitachi Medical Systems America, Inc.: 4 (https://510kreport.com/company/hitachi-medical-systems-america)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical: 1 (https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)

## Firms that cite its devices most
- Fujifilm Healthcare Corporation: 4 (https://510kreport.com/company/fujifilm-healthcare)
- FUJIFILM Healthcare Americas Corporation: 1 (https://510kreport.com/company/fujifilm-healthcare-americas)

## Its most-cited devices
- K183456: Aloka Arietta 850 (2019), cited by 2
- K173739: Aloka Arietta 850 (2018), cited by 2
- K181376: Arietta 65 (2018), cited by 2
- K171738: Supria True64 (2017), cited by 2
- K202030: OASIS MRI System (2020), cited by 1
- K200498: SCENARIA View (2020), cited by 1

## Recent decisions
- K211406: OASIS MRI System (Oct 7, 2021)
- K202422: Arietta 65 (Nov 4, 2020)
- K202030: OASIS MRI System (Oct 21, 2020)
- K200498: SCENARIA View (Jul 17, 2020)
- K192851: OASIS MRI System (Feb 21, 2020)
- K190841: SCENARIA View (Sep 13, 2019)
- K191233: Arietta 750 (Aug 9, 2019)
- K190248: Arietta 50 (Apr 2, 2019)

Source page: https://510kreport.com/company/hitachi-healthcare-americas