The following data is part of a premarket notification filed by Segana, Inc. with the FDA for Rtapp.
Device ID | K212887 |
510k Number | K212887 |
Device Name: | RTapp |
Classification | System, Image Processing, Radiological |
Applicant | SegAna, Inc. 3259 Progress Drive Orlando, FL 32826 |
Contact | Jennifer Bosley |
Correspondent | Jennifer Bosley SegAna, Inc. 3259 Progress Drive Orlando, FL 32826 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-10 |
Decision Date | 2021-11-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RTAPP 88461967 not registered Live/Pending |
Segana LLC 2019-06-06 |