The following data is part of a premarket notification filed by Hitachi Aloka Medical,ltd. (hitachi Aloka Medical with the FDA for Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0.
| Device ID | K122537 |
| 510k Number | K122537 |
| Device Name: | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Richard J Cehovsky |
| Correspondent | Michael S Ogunleye TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869047000424 | K122537 | 000 |
| 04562122956826 | K122537 | 000 |
| 04562122956819 | K122537 | 000 |
| 04562122955607 | K122537 | 000 |
| 04562122955577 | K122537 | 000 |
| 04562122955560 | K122537 | 000 |
| 04562122955331 | K122537 | 000 |
| 04562122954990 | K122537 | 000 |
| 04562122954310 | K122537 | 000 |
| 04562122954297 | K122537 | 000 |
| 04562122954037 | K122537 | 000 |
| 04573596212936 | K122537 | 000 |
| 00860007188336 | K122537 | 000 |
| 00860007188329 | K122537 | 000 |
| 00860007188312 | K122537 | 000 |
| 04562122956833 | K122537 | 000 |
| 04562122956840 | K122537 | 000 |
| 00869047000417 | K122537 | 000 |
| 00869047000400 | K122537 | 000 |
| 04562122957816 | K122537 | 000 |
| 04562122957809 | K122537 | 000 |
| 04562122957793 | K122537 | 000 |
| 04562122957786 | K122537 | 000 |
| 04562122957762 | K122537 | 000 |
| 04562122957489 | K122537 | 000 |
| 04562122957342 | K122537 | 000 |
| 04562122957335 | K122537 | 000 |
| 04562122957021 | K122537 | 000 |
| 04562122956871 | K122537 | 000 |
| 04562122956864 | K122537 | 000 |
| 04562122956857 | K122537 | 000 |
| 00860007188343 | K122537 | 000 |