SoftVue
System, Imaging, Pulsed Echo, Ultrasonic
Delphinus Medical Technologies
The following data is part of a premarket notification filed by Delphinus Medical Technologies with the FDA for Softvue.
Pre-market Notification Details
| Device ID | K172256 |
| 510k Number | K172256 |
| Device Name: | SoftVue |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Delphinus Medical Technologies 45525 Grand River Avenue Novi, MI 48374 |
| Contact | Francis X. Dobscha |
| Correspondent | Jillian M. Reed Delphinus Medical Technologies 45525 Grand River Avenue Novi, MI 48374 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-26 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
Trademark Results [SoftVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTVUE 87043815 not registered Live/Pending |
Delphinus Medical Technologies, Inc. 2016-05-19 |
 SOFTVUE 74514735 not registered Dead/Abandoned |
O.S.I. Corporation 1994-04-15 |
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