Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K221106 |
Device Name |
Quantib Prostate |
Applicant |
Quantib BV |
Westblaak 106 |
Rotterdam,
NL
3012 KM
|
|
Applicant Contact |
Arnault Massink |
Correspondent |
Quantib BV |
Westblaak 106 |
Rotterdam,
NL
3012 KM
|
|
Correspondent Contact |
Arnault Massink |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/15/2022 |
Decision Date | 05/13/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|