FDA 510(k) Application Details - K240705

Device Classification Name System, Image Processing, Radiological

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510(K) Number K240705
Device Name System, Image Processing, Radiological
Applicant Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi 324-8550 JP
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Contact Paul Biggins
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/14/2024
Decision Date 07/17/2024
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

FDA Source Information for K240705


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