The following data is part of a premarket notification filed by Deepvoxel Inc with the FDA for Dv. Target.
Device ID | K202928 |
510k Number | K202928 |
Device Name: | DV. Target |
Classification | Radiological Image Processing Software For Radiation Therapy |
Applicant | Deepvoxel INC 22 Talisman Irvine, CA 92620 |
Contact | Jerry Liu |
Correspondent | Albert Rego Albert Rego, PhD, Inc. 27001 La Paz Road, Suite #314 Mission Viejo, CA 92691 |
Product Code | QKB |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-29 |
Decision Date | 2021-04-02 |