Saige-Q
Radiological Computer-assisted Prioritization Software For Lesions
DeepHealth, Inc.
The following data is part of a premarket notification filed by Deephealth, Inc. with the FDA for Saige-q.
Pre-market Notification Details
| Device ID | K203517 |
| 510k Number | K203517 |
| Device Name: | Saige-Q |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | DeepHealth, Inc. 1000 Massachusetts Ave Cambridge, MA 02138 |
| Contact | A. Gregory Sorensen |
| Correspondent | A Gregory Sorensen DeepHealth, Inc. 1000 Massachusetts Ave Cambridge, MA 02138 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2021-04-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005144006 | K203517 | 000 |
Trademark Results [Saige-Q]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAIGE-Q 90258964 not registered Live/Pending |
Deephealth 2020-10-16 |
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