The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Dus-6000 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K172931 |
| 510k Number | K172931 |
| Device Name: | DUS-6000 Digital Ultrasonic Diagnostic Imaging System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Advanced Instrumentations, Inc. 6800 NW 77th Ct Miami, FL 33166 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan Advanced Instrumentations, Inc. 6800 NW 77th Ct Miami, FL 33166 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2017-12-01 |
| Summary: | summary |