The following data is part of a premarket notification filed by Intelerad Medical Systems Inc. with the FDA for Intelepacs.
| Device ID | K070080 |
| 510k Number | K070080 |
| Device Name: | INTELEPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | INTELERAD MEDICAL SYSTEMS INC. 460 STE-CATHERINE WEST SUITE 210 Montreal Quebec, CA M3b 1a7 |
| Contact | Anibal Jodorcovsky |
| 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 | 2007-01-09 |
| Decision Date | 2007-01-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INTELEPACS 98602152 not registered Live/Pending |
Intelerad Medical Systems Incorporated 2024-06-14 |
![]() INTELEPACS 76502444 2816702 Live/Registered |
Intelerad Medical Systems Incorporated 2003-03-31 |
![]() INTELEPACS 75251634 not registered Dead/Abandoned |
INTELEMED, L.L.C. 1997-03-03 |