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 |