Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K213766 |
Device Name |
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T |
Applicant |
Invivo Corporation |
3545 SW 47th Ave |
Gainesville,
FL
32608
|
|
Applicant Contact |
Ann Lebar |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 12/01/2021 |
Decision Date | 12/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|