The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-alpha 7 Ultrasound System.
| Device ID | K072285 |
| 510k Number | K072285 |
| Device Name: | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard J Cehovsky |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2007-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958912 | K072285 | 000 |
| 04562122951708 | K072285 | 000 |
| 04562122951715 | K072285 | 000 |
| 04562122951722 | K072285 | 000 |
| 04562122956260 | K072285 | 000 |
| 04562122956284 | K072285 | 000 |
| 04562122957205 | K072285 | 000 |
| 04562122957212 | K072285 | 000 |
| 04562122957229 | K072285 | 000 |
| 04562122951616 | K072285 | 000 |