AnatomicAligner
System, Image Processing, Radiological
The Methodist Hospital Research Institute D/b/a Houston
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.
Pre-market Notification Details
| 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 |
Trademark Results [AnatomicAligner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANATOMICALIGNER 87622985 5639148 Live/Registered |
The Methodist Hospital 2017-09-26 |
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