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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K221632
Device Name Spine CAMP™
Medical Metrics, Inc.
2121 Sage Road
Houston,  TX  77056
Applicant Contact Kirk Johnson
Medical Metrics, Inc.
2121 Sage Road
Houston,  TX  77056
Correspondent Contact Kirk Johnson
Regulation Number892.2050
Classification Product Code
Date Received06/06/2022
Decision Date 10/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No