The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-3500 Diagnostic Ultrasound System.
| Device ID | K111227 |
| 510k Number | K111227 |
| Device Name: | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Yukitoshi Kiyomura |
| Correspondent | Michael S Ogunleye TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| 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 | 2011-05-02 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122956154 | K111227 | 000 |
| 04562122955959 | K111227 | 000 |
| 04562122954730 | K111227 | 000 |
| 04573596213438 | K111227 | 000 |
| 04573596212981 | K111227 | 000 |