FDA 510(k) Application Details - K203281

Device Classification Name

  More FDA Info for this Device
510(K) Number K203281
Device Name Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
Applicant medPhoton GmbH
Karolingerstra▀e 16
Salzburg 5020 AT
Other 510(k) Applications for this Company
Contact Daniel Schaffarzick
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 11/06/2020
Decision Date 12/22/2020
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