The following data is part of a premarket notification filed by Medlink Imaging with the FDA for Uniscan, Pulmoscan, Pulmoscan Radiographic Systems.
| Device ID | K033577 |
| 510k Number | K033577 |
| Device Name: | UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS |
| Classification | System, X-ray, Stationary |
| Applicant | MEDLINK IMAGING P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MEDLINK IMAGING P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2005-03-18 |
| Summary: | summary |