FDA 510(k) Application Details - K191662

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K191662
Device Name System, Nuclear Magnetic Resonance Imaging
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 892.1000

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

  More FDA Info for this Product Code
Date Received 06/21/2019
Decision Date 07/23/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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