SubtleMR
System, Image Processing, Radiological
Subtle Medical, Inc.
The following data is part of a premarket notification filed by Subtle Medical, Inc. with the FDA for Subtlemr.
Pre-market Notification Details
| Device ID | K191688 |
| 510k Number | K191688 |
| Device Name: | SubtleMR |
| Classification | System, Image Processing, Radiological |
| Applicant | Subtle Medical, Inc. 883 Santa Cruz Ave, Suite 205 Menlo Park, CA 94025 |
| Contact | Ajit Shankaranarayanan |
| Correspondent | Jared Seehafer Enzyme Corporation 360 Langton St. Ste. 100 San Francisco, CA 94103 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-09-16 |
| Summary: | summary |
Trademark Results [SubtleMR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUBTLEMR 97024929 not registered Live/Pending |
Subtle Medical, Inc. 2021-09-13 |
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