Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K192554 |
Device Name |
decimal3D |
Applicant |
.decimal, LLC. |
121 Central Park PL |
Sanford,
FL
32771
|
|
Applicant Contact |
Kevin Erhart |
Correspondent |
.decimal, LLC. |
121 Central Park PL |
Sanford,
FL
32771
|
|
Correspondent Contact |
Kevin Erhart |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 09/17/2019 |
Decision Date | 12/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|