The following data is part of a premarket notification filed by Intelligent Images Srl with the FDA for Compacs, Version 1.0.
| Device ID | K041581 |
| 510k Number | K041581 |
| Device Name: | COMPACS, VERSION 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | INTELLIGENT IMAGES SRL VIALE CEMBRANO 4C/4 Genova (ge), IT I-16148 |
| Contact | Maurizio Paiggio |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-06-22 |
| Summary: | summary |