The following data is part of a premarket notification filed by Advanced Instrument Development, Inc. with the FDA for Imix Digital Thorax System.
| Device ID | K974863 |
| 510k Number | K974863 |
| Device Name: | IMIX DIGITAL THORAX SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | ADVANCED INSTRUMENT DEVELOPMENT, INC. 1011 NORTH 25TH AVE. Melrose Park, IL 60160 |
| Contact | James M Taylor |
| Correspondent | James M Taylor ADVANCED INSTRUMENT DEVELOPMENT, INC. 1011 NORTH 25TH AVE. Melrose Park, IL 60160 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-03-17 |