The following data is part of a premarket notification filed by Hitachi, Ltd. with the FDA for Arietta Prologue Diagnostic Ultrasound System And Transducers.
| Device ID | K162902 |
| 510k Number | K162902 |
| Device Name: | ARIETTA Prologue Diagnostic Ultrasound System And Transducers |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI, LTD. 10 FAIRFIELD BOULEVARD Wallingford, CT 06492 -5903 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI, LTD. 10 FAIRFIELD BOULEVARD Wallingford, CT 06492 -5903 |
| 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 | 2016-10-17 |
| Decision Date | 2016-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958738 | K162902 | 000 |
| 04562122958721 | K162902 | 000 |
| 04573596214121 | K162902 | 000 |