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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K192196
Device Name Medical Radiation Dosimetry System microSTARii
2 Science Rd.
Glenwood,  IL  60425
Applicant Contact Matt Ennis
2 Science Rd.
Glenwood,  IL  60425
Correspondent Contact Matt Ennis
Regulation Number892.5050
Classification Product Code
Date Received08/13/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls