The following data is part of a premarket notification filed by Heart Imaging Technologies, Llc with the FDA for Webpax.
Device ID | K152949 |
510k Number | K152949 |
Device Name: | WebPAX |
Classification | System, Image Processing, Radiological |
Applicant | HEART IMAGING TECHNOLOGIES, LLC 5003 SOUTHPARK DR. SUITE 140 Durham, NC 27713 |
Contact | Robert Judd |
Correspondent | Robert Judd HEART IMAGING TECHNOLOGIES, LLC 5003 SOUTHPARK DR. SUITE 140 Durham, NC 27713 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-06 |
Decision Date | 2016-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B127WP90 | K152949 | 000 |
B228INTELEHEART0 | K152949 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WEBPAX 87245735 5367808 Live/Registered |
Heart Imaging Technologies, LLC 2016-11-22 |
WEBPAX 78397860 not registered Dead/Abandoned |
FT11 Interactive 2004-04-07 |
WEBPAX 76572154 3080189 Dead/Cancelled |
Heart Imaging Technologies, LLC 2004-01-22 |