Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K203249 |
Device Name |
Nucleus.io |
Applicant |
NucleusHealth, LLC |
13280 Evening Creek Dr. |
Ste 110 |
San Diego,
CA
92128
|
|
Applicant Contact |
Zachary Wright |
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 | 11/04/2020 |
Decision Date | 12/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|