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FDA 510(k) Application Details - K222195
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K222195
Device Name
System, Image Processing, Radiological
Applicant
Carlsmed, Inc.
1800 Aston Ave., Ste 100
Carlsbad, CA 92008 US
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Contact
Karen Liu
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
07/22/2022
Decision Date
12/30/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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