The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Impax Ot3000 Orthopedic Workstation.
| Device ID | K040344 |
| 510k Number | K040344 |
| Device Name: | IMPAX OT3000 ORTHOPEDIC WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA CORP. 455 PHILIP STREET Waterloo, Ontario, CA N2l 3x2 |
| Contact | Phil Cuscuna |
| Correspondent | Phil Cuscuna AGFA CORP. 455 PHILIP STREET Waterloo, Ontario, CA N2l 3x2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-12 |
| Decision Date | 2004-05-12 |
| Summary: | summary |