Device Classification Name |
cabinet, x-ray system
|
510(k) Number |
K213691 |
Device Name |
Solas OR |
Applicant |
Cirdan Imaging Ltd |
The Green, Tullynacross Rd, Lambeg |
Lisburn,
GB
BT27 5SR
|
|
Applicant Contact |
Paul Matthews |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 11/23/2021 |
Decision Date | 12/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|