The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Prosound F75 Diagnostic Ultrasound System.
| Device ID | K123828 |
| 510k Number | K123828 |
| Device Name: | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -5903 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. 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 | 2012-12-12 |
| Decision Date | 2013-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958011 | K123828 | 000 |