510(k) K190049

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 17, 2019

Date Received

January 10, 2019

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Software For Visualization Of Vascular Anatomy And Intravascular Devices

Device Class

Class II

Regulation Number

892.2050

Review Panel

CV

Submission Type

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.