The following data is part of a premarket notification filed by Intelerad Medical Systems Incorporated with the FDA for Intelepacs.
Device ID | K192176 |
510k Number | K192176 |
Device Name: | IntelePACS |
Classification | System, Image Processing, Radiological |
Applicant | Intelerad Medical Systems Incorporated 800 Boul. De Maisonneuve Est., 12th Floor Montreal, CA H2l4l8 |
Contact | Luce Caron |
Correspondent | Carl Alletto OTech Inc. 215 E University Dr., Suite B Denton, TX 76209 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-12 |
Decision Date | 2020-04-02 |
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 |