The following data is part of a premarket notification filed by Hitachi, Ltd with the FDA for Arietta Precision.
| Device ID | K163505 |
| 510k Number | K163505 |
| Device Name: | ARIETTA PRECISION |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI, LTD 10 FAIRFIELD BOULEVARD Wallingford, CT 06492 -5903 |
| Contact | Angela Van Arsdale |
| Correspondent | Doug J Thistlethwaite HITACHI, LTD 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-14 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958820 | K163505 | 000 |
| 04562122958707 | K163505 | 000 |
| 04573596214114 | K163505 | 000 |
| 04573596212134 | K163505 | 000 |