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 |