The following data is part of a premarket notification filed by Hitachi Aloka Medical America, Inc. with the FDA for Intra-operative Ultrasound Transducer, Prosound Alpha 7 Diagnostic Ultrasound System, Arietta 70 Diagnostic Ultrasound System.
| Device ID | K142618 |
| 510k Number | K142618 |
| Device Name: | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Hitachi Aloka Medical America, Inc. 10 Fairfield Blvd Wallingford, CT 06492 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale Hitachi Aloka Medical America, Inc. 10 Fairfield Blvd Wallingford, CT 06492 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2014-10-16 |
| Summary: | summary |