The following data is part of a premarket notification filed by Fujifilm Healthcare Corporation with the FDA for Arietta 50.
| Device ID | K220295 |
| 510k Number | K220295 |
| Device Name: | ARIETTA 50 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM Healthcare Corporation 2-1, Shintoyofuta Kashiwa-shi, JP 277-0804 |
| Contact | Randy Vader |
| Correspondent | Dennis Domoracki FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-04-29 |