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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 K242748
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 Received09/12/2024
Decision Date 04/11/2025
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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