The following data is part of a premarket notification filed by Intelerad Medical Systems Incorporated with the FDA for Intelepacs, Model Version 3.x.x.
| Device ID | K083520 |
| 510k Number | K083520 |
| Device Name: | INTELEPACS, MODEL VERSION 3.X.X |
| Classification | System, Image Processing, Radiological |
| Applicant | INTELERAD MEDICAL SYSTEMS INCORPORATED 895 DE LA GAUCHETIERE ST WEST, SUITE 400 Montreal, Qb, CA H3b 4g1 |
| Contact | Anibal Jodorcovsky |
| Correspondent | Anibal Jodorcovsky INTELERAD MEDICAL SYSTEMS INCORPORATED 895 DE LA GAUCHETIERE ST WEST, SUITE 400 Montreal, Qb, CA H3b 4g1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-06-23 |