The following data is part of a premarket notification filed by Etiam S.a.s.u. with the FDA for Etiam Pacs Components.
| Device ID | K131392 |
| 510k Number | K131392 |
| Device Name: | ETIAM PACS COMPONENTS |
| Classification | System, Image Processing, Radiological |
| Applicant | ETIAM S.A.S.U. 2 RUE PIERRE JOSEPH COLIN Rennes, FR 35000 |
| Contact | Geraldine Tessens |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-05-29 |
| Summary: | summary |