The following data is part of a premarket notification filed by The Methodist Hospital Research Institute D/b/a Houston with the FDA for Anatomicaligner.
Device ID | K190767 |
510k Number | K190767 |
Device Name: | AnatomicAligner |
Classification | System, Image Processing, Radiological |
Applicant | The Methodist Hospital Research Institute D/b/a Houston Methodist Research Institute 6670 Bertner Avenue Houston, TX 77030 |
Contact | Christina Talley |
Correspondent | Christina Talley The Methodist Hospital Research Institute D/b/a Houston Methodist Research Institute 6670 Bertner Avenue Houston, TX 77030 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-25 |
Decision Date | 2020-03-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANATOMICALIGNER 87622985 5639148 Live/Registered |
The Methodist Hospital 2017-09-26 |