The following data is part of a premarket notification filed by Hitachi Healthcare Americas Corporation with the FDA for Arietta 65.
| Device ID | K181376 |
| 510k Number | K181376 |
| Device Name: | ARIETTA 65 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Hitachi Healthcare Americas Corporation 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite Hitachi Healthcare Americas Corporation 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 | 2018-05-24 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122959308 | K181376 | 000 |
| 04573596214381 | K181376 | 000 |
| 04573596211359 | K181376 | 000 |
| 04573596212073 | K181376 | 000 |
| 04573596212233 | K181376 | 000 |
| 04573596213889 | K181376 | 000 |
| 04562122959278 | K181376 | 000 |
| 04562122959285 | K181376 | 000 |
| 04562122959292 | K181376 | 000 |
| 04573596214510 | K181376 | 000 |