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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K222803
Device Name Oncospace
Applicant
Oncospace, Inc.
1812 Ashland Ave., Suite 100k
Baltimore,  MD  21205
Applicant Contact Sigrid Schoepel
Correspondent
Oncospace, Inc.
1812 Ashland Ave., Suite 100k
Baltimore,  MD  21205
Correspondent Contact Sigrid Schoepel
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/16/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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