The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Electronic Ultrasound Scan Models Eup-u12/012t/tc3.
| Device ID | K912363 |
| 510k Number | K912363 |
| Device Name: | ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Takguchi |
| Correspondent | Takguchi HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1991-08-27 |