The following data is part of a premarket notification filed by Mirada Solutions Ltd. with the FDA for Rtist.
| Device ID | K033955 |
| 510k Number | K033955 |
| Device Name: | RTIST |
| Classification | System, Image Processing, Radiological |
| Applicant | MIRADA SOLUTIONS LTD. CTI MOLECULAR IMAGING, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Contact | Maria Ebio |
| Correspondent | Maria Ebio MIRADA SOLUTIONS LTD. CTI MOLECULAR IMAGING, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-03-17 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RTIST 87187673 5601908 Live/Registered |
Paris Presents Incorporated 2016-09-29 |
![]() RTIST 78349359 3365577 Dead/Cancelled |
Miranda Solutions Limited 2004-01-08 |