Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K241567 |
Device Name |
MC2 Portable X-ray System |
Applicant |
Oxos Medical |
1100 Peachtree St NE |
Ste 700 |
Atlanta,
GA
30309
|
|
Applicant Contact |
Dhruv Vishwakarma |
Correspondent |
Powers Regulatory Consulting |
1100 Peachtree St NE |
STE 700 |
Atlanta,
GA
30309
|
|
Correspondent Contact |
Dhruv Vishwakarma |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/31/2024 |
Decision Date | 12/06/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|