The following data is part of a premarket notification filed by Hitachi Aloka Medical America, Inc. with the FDA for Hi Vision Ascendus, Hv Ascendus, Ascendus.
| Device ID | K153421 |
| 510k Number | K153421 |
| Device Name: | HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL AMERICA, INC. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI ALOKA MEDICAL AMERICA, INC. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| 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 | 2015-11-25 |
| Decision Date | 2016-01-21 |
| Summary: | summary |