The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eup-012i, Eup-012j & Eub-0124 Ultrasonic Scanner.
| Device ID | K862164 |
| 510k Number | K862164 |
| Device Name: | EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Medical Syst |
| Correspondent | Medical Syst HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-06 |
| Decision Date | 1986-11-04 |