# Hitachi Medical Systems America, Inc.

- Location (FDA's records): Twinsburg, OH
- FDA decisions: 100 (1991–2017): 100 510(k) clearances
- Product codes: LNH (54), MOS (18), JAK (12), IYN (5), IYO (2), LNI (2), KPS (1), JAA (1), DQA (1), LLZ (1), IZI (1), MUH (1)
- 510(k) review time since 2016: median 77 days, against 108 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 60 (43 its own); citations of its devices by later devices: 99 (43 its own)
- Recalls linked to its devices: 38 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Cti Pet Systems, Inc.: 2 (https://510kreport.com/company/cti-pet-systems)
- Igc-Medical Advances, Inc.: 1 (https://510kreport.com/company/igc-medical-advances)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Ge Medical Systems Ultrasound and Primary Care Dia: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-dia)
- Mbf Sales, LLC: 1 (https://510kreport.com/company/mbf-sales)
- Hitachi Medical Corp. of America: 1 (https://510kreport.com/company/hitachi-medical-of-america)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Pentax Medical Company: 4 (https://510kreport.com/company/pentax-medical)
- Hitachi Healthcare Americas: 4 (https://510kreport.com/company/hitachi-healthcare-americas)
- Beijing Wandong Medical Equipment Co., Ltd.: 4 (https://510kreport.com/company/beijing-wandong-medical-equipment)
- Esaote, S.p.A.: 4 (https://510kreport.com/company/esaote)
- Pentax Precision Instrument Corp.: 3 (https://510kreport.com/company/pentax-precision-instrument)
- Biosound, Inc.: 3 (https://510kreport.com/company/biosound)
- Millennium Technology Services: 3 (https://510kreport.com/company/millennium-technology-services)
- Hitachi Aloka Medical, Ltd.: 2 (https://510kreport.com/company/hitachi-aloka-medical)

## Its most-cited devices
- K974212: Airis II (1998), cited by 10
- K001334: Hitachi Airis II (2000), cited by 8
- K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus (2010), cited by 6
- K063518: HI Vision 900 Diagnostic Ultrasound Scanner (2006), cited by 5
- K040902: Hitachi Presto (2004), cited by 4
- K052172: HHF1 Magnetic Resonance Imaging System (2005), cited by 4

## Recent decisions
- K163528: HITACHI Supria Whole-body X-ray CT System Phase 3 (Mar 3, 2017)
- K162079: TRILLIUM Oval Head Coil 32 (Sep 16, 2016)
- K161748: SUPRIA w/guideShot Option (Aug 17, 2016)
- K160152: Trillium Oval V 5.1 MRI System (May 20, 2016)
- K153547: ECHELON Oval V 5.1 MRI System (Mar 31, 2016)
- K150595: SCENARIA Phase 3 Whole-body X-ray CT System (Oct 30, 2015)
- K150565: Supria Whole-body X-ray CT System (Sep 30, 2015)
- K151015: ECHELON Oval V 5.0 MRI System (Jul 29, 2015)

Source page: https://510kreport.com/company/hitachi-medical-systems-america