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 |