# Hitachi Medical Corp. of America

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 32 (1985–2000): 32 510(k) clearances
- Product codes: IYO (12), ITX (6), KPS (5), DXK (4), IYN (2), HGL (1), IZI (1), JAF (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 17 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Adac Laboratories: 4 (https://510kreport.com/company/adac-laboratories)

## Firms that cite its devices most
- Pentax Precision Instrument Corp.: 6 (https://510kreport.com/company/pentax-precision-instrument)
- Shantou Institute of Ultrasonic Instuments: 4 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instuments)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)
- Biosound, Inc.: 1 (https://510kreport.com/company/biosound)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Biosound Esaote, Inc.: 1 (https://510kreport.com/company/biosound-esaote)
- Fujinon, Inc.: 1 (https://510kreport.com/company/fujinon)

## Its most-cited devices
- K994026: Eub-6000 Ultrasound Diagnostic Scanner (2000), cited by 5
- K862867: Eub-310 Ultrasonic Scanner (1987), cited by 3
- K981434: Eup-OL334 Laparascopicprobe (1998), cited by 3
- K884644: Addit. Trans. Eup-B31/033J/V33/U33/032T/L33/U322 (1990), cited by 2
- K862164: Eup-012I, Eup-012J & Eub-0124 Ultrasonic Scanner (1986), cited by 1
- K945400: Hitachi Dynamic 3D Imaging System,SF-VA100 (1995), cited by 1

## Recent decisions
- K994026: Eub-6000 Ultrasound Diagnostic Scanner (Mar 29, 2000)
- K991535: Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras (Jul 30, 1999)
- K991318: Convergence Nua for Hitachi Spectradigital V250DSP Gamma Cameras (Jun 18, 1999)
- K991129: Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal (TI) Crystal (May 13, 1999)
- K981434: Eup-OL334 Laparascopicprobe (Jul 27, 1998)
- K954220: EUB-8000 (May 7, 1997)
- K962308: EUB-905 (Jul 17, 1996)
- K954129: Spectradigital Series V250DSP (Dec 22, 1995)

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