Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K231668 |
Device Name |
Spine CAMP™ (1.1) |
Applicant |
Medical Metrics, Inc. |
2121 Sage Road |
Suite 300 |
Houston,
TX
77056
|
|
Applicant Contact |
Kirk Johnson |
Correspondent |
Medical Metrics, Inc. |
2121 Sage Road |
Suite 300 |
Houston,
TX
77056
|
|
Correspondent Contact |
Kirk Johnson |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/07/2023 |
Decision Date | 07/07/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|