Device Classification Name |
Radiological Image Processing Software For Radiation Therapy
|
510(k) Number |
K203610 |
Device Name |
Automatic Anatomy Recognition (AAR) |
Applicant |
Quantitative Radiology Solutions, LLC |
3675 Market Street, Suite 200 |
Philadelphia,
PA
19104
|
|
Applicant Contact |
Steve Owens |
Correspondent |
Medical Device Academy |
345 Lincoln Hill Rd. |
Shrewsbury,
VT
05738
|
|
Correspondent Contact |
Mary Vater |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/10/2020 |
Decision Date | 04/20/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|