# Hitachi Medical Corp.

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 12 (1982–2016): 12 510(k) clearances
- Names in FDA's records: Hitachi Medical Corp. (11); Hitachi Medical Corporation (1)
- Product codes: IYN (5), ITX (2), IYO (2), DQA (1), MOS (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 13 (2 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Firms that cite its devices most
- Pentax Precision Instrument Corp.: 3 (https://510kreport.com/company/pentax-precision-instrument)
- Techdevice Corporation: 1 (https://510kreport.com/company/techdevice)
- Fukuda Denshi USA, Inc.: 1 (https://510kreport.com/company/fukuda-denshi-usa)
- Esaote, S.p.A.: 1 (https://510kreport.com/company/esaote)
- Hitachi Healthcare Americas: 1 (https://510kreport.com/company/hitachi-healthcare-americas)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)
- Hamamatsu Photonics K.K.: 1 (https://510kreport.com/company/hamamatsu-photonics)

## Its most-cited devices
- K042501: Etg-4000 Optical Topography System (2004), cited by 3
- K011252: Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System (2001), cited by 3
- K013722: Modification to: Eub-8500 Diagnostic Ultrasound Scanner (2002), cited by 3
- K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner (2002), cited by 2
- K053258: Eub-6500 Diagnostic Ultrasound Scanner (2005), cited by 2

## Recent decisions
- K160559: NOBLUS™ Ultrasound Diagnostic System (Oct 18, 2016)
- K073310: Oasis CTL Coil, OD Flexible Body Coil (L and XL), and Rapid Foot Coil (Jan 18, 2008)
- K061608: Modification to Eub-5500 Diagnostic Ultrasound Scanner (Nov 22, 2006)
- K053258: Eub-6500 Diagnostic Ultrasound Scanner (Dec 9, 2005)
- K042501: Etg-4000 Optical Topography System (Oct 12, 2004)
- K013722: Modification to: Eub-8500 Diagnostic Ultrasound Scanner (Feb 11, 2002)
- K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner (Feb 6, 2002)
- K012239: Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; SP-711 Sonoprobe System (Aug 10, 2001)

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