The following data is part of a premarket notification filed by Etiam, S.a. with the FDA for Etiam Star Pacs Components.
| Device ID | K052358 |
| 510k Number | K052358 |
| Device Name: | ETIAM STAR PACS COMPONENTS |
| Classification | System, Image Processing, Radiological |
| Applicant | ETIAM, S.A. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto ETIAM, S.A. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-05 |
| Summary: | summary |