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 |