The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Impax Orthopaedic Workstation, Model Impax Es 5.x.
| Device ID | K050751 |
| 510k Number | K050751 |
| Device Name: | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Phil Cuscuna |
| Correspondent | Phil Cuscuna AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2005-04-21 |
| Summary: | summary |