ORTHOPACS
System, Image Processing, Radiological
ETRAUMA.COM CORP.
The following data is part of a premarket notification filed by Etrauma.com Corp. with the FDA for Orthopacs.
Pre-market Notification Details
| Device ID | K033825 |
| 510k Number | K033825 |
| Device Name: | ORTHOPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | ETRAUMA.COM CORP. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro ETRAUMA.COM CORP. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-02-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100348 | K033825 | 000 |
| 00842000100089 | K033825 | 000 |
| 00842000100454 | K033825 | 000 |
Trademark Results [ORTHOPACS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOPACS 78489920 not registered Dead/Abandoned |
Dynamic Imaging, LLC 2004-09-27 |
 ORTHOPACS 78303840 not registered Dead/Abandoned |
NovaRad 2003-09-22 |
 ORTHOPACS 76366962 2836953 Dead/Cancelled |
STRYKER IMAGING CORPORATION 2002-02-06 |
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