The following data is part of a premarket notification filed by American Medical Sales, Inc. with the FDA for Catella Diagnostic Workstation, Version 4.0.
| Device ID | K052537 |
| 510k Number | K052537 |
| Device Name: | CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | AMERICAN MEDICAL SALES, INC. 4928 WEST ROSECRANS AVE. Hawthorne, CA 90250 -6616 |
| Contact | Carol M Lifland |
| Correspondent | Carol M Lifland AMERICAN MEDICAL SALES, INC. 4928 WEST ROSECRANS AVE. Hawthorne, CA 90250 -6616 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-15 |
| Decision Date | 2005-11-16 |
| Summary: | summary |