The following data is part of a premarket notification filed by Ikoetech, Llc. with the FDA for Ikoengelo.
| Device ID | K061006 | 
| 510k Number | K061006 | 
| Device Name: | IKOENGELO | 
| Classification | System, Simulation, Radiation Therapy | 
| Applicant | IKOETECH, LLC. 3000 RICHMOND, SUITE 200 Houston, TX 77098 | 
| Contact | Huimin Chao | 
| Correspondent | Huimin Chao IKOETECH, LLC. 3000 RICHMOND, SUITE 200 Houston, TX 77098 | 
| Product Code | KPQ | 
| Subsequent Product Code | IYE | 
| Subsequent Product Code | MUJ | 
| CFR Regulation Number | 892.5840 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2006-04-11 | 
| Decision Date | 2006-06-05 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  IKOENGELO  78764960  3406906 Dead/Cancelled | VARIAN MEDICAL SYSTEMS, INC. 2005-12-01 |