Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K212175 |
Device Name |
DynaCAD |
Applicant |
Invivo Corporation |
3545 SW 47th Ave |
Gainesville,
FL
32608
|
|
Applicant Contact |
Liselotte Kornmann |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/12/2021 |
Decision Date | 08/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|