FDA 510(k) Application Details - K202349

Device Classification Name System, Tomography, Computed, Emission

  More FDA Info for this Device
510(K) Number K202349
Device Name System, Tomography, Computed, Emission
Applicant Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi 324-8550 JP
Other 510(k) Applications for this Company
Contact Paul Biggins
Other 510(k) Applications for this Contact
Regulation Number 892.1200

  More FDA Info for this Regulation Number
Classification Product Code KPS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/18/2020
Decision Date 10/15/2020
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact