The following data is part of a premarket notification filed by Imed Systems & Consulting, Llc. with the FDA for Telepax.
| Device ID | K011173 | 
| 510k Number | K011173 | 
| Device Name: | TELEPAX | 
| Classification | System, Image Processing, Radiological | 
| Applicant | IMED SYSTEMS & CONSULTING, LLC. 4715 TRAIL COURT Westminster, MD 21158 | 
| Contact | Kenneth P Bonner | 
| Correspondent | Kenneth P Bonner IMED SYSTEMS & CONSULTING, LLC. 4715 TRAIL COURT Westminster, MD 21158 | 
| Product Code | LLZ | 
| CFR Regulation Number | 892.2050 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Abbreviated | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2001-04-17 | 
| Decision Date | 2001-07-11 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TELEPAX  77020062  3310543 Live/Registered | Healthy-IT, LLC 2006-10-12 | 
|  TELEPAX  74461509  1884894 Dead/Cancelled | SERTONS INTERNATIONAL B.V. 1993-11-12 |