Device Classification Name |
Radiological Image Processing Software For Radiation Therapy
|
510(k) Number |
K202928 |
Device Name |
DV. Target |
Applicant |
Deepvoxel INC |
22 Talisman |
Irvine,
CA
92620
|
|
Applicant Contact |
Jerry Liu |
Correspondent |
Albert Rego, PhD, Inc. |
27001 La Paz Road, Suite #314 |
Mission Viejo,
CA
92691
|
|
Correspondent Contact |
Albert Rego |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2020 |
Decision Date | 04/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|