The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for Dx-480, Add On Digital Imager.
| Device ID | K981880 |
| 510k Number | K981880 |
| Device Name: | DX-480, ADD ON DIGITAL IMAGER |
| Classification | System, X-ray, Stationary |
| Applicant | WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037 |
| Contact | David Andress |
| Correspondent | David Andress WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-28 |
| Decision Date | 1998-10-20 |