KPS — System, Tomography, Computed, Emission Class II

FDA Device Classification

Classification Details

Product Code
KPS
Device Class
Class II
Regulation Number
892.1200
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253564shanghai united imaging healthcare couMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI PanvivoFebruary 13, 2026
K254001spectrum dynamics medicalVERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4January 13, 2026
K253844mediso medical imaging systemsAnyScan 3.0 NM Scanner FamilyDecember 30, 2025
K251370canon medical systems corporationCartesion Prime (PCD-1000A/3) V10.21December 1, 2025
K251401trustees of the university of pennsylvaniaPennPET Explorer Positron Emission TomographNovember 25, 2025
K252477hermes medical solutionsHybrid Viewer (00859873006240)September 9, 2025
K250170brightonix imagingPHAROSAugust 15, 2025
K251561siemens medical solutions usaBiograph TrinionJuly 31, 2025
K251839shanghai united imaging healthcare couMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)July 17, 2025
K251671siemens medical solutions usaBiograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsJuly 3, 2025
K251153ge medical systems israelAuroraJune 12, 2025
K243881bracco diagnosticsHeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and CoronaMarch 3, 2025
K241266raysolution healthcare coImaging system of positron emission and X-ray computed tomography (DigitMI 930)January 27, 2025
K243605ge medical systems israel, functional imagingAuroraJanuary 17, 2025
K243538shanghai united imaging healthcare couMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)December 12, 2024
K241364hermes medical solutionsHybrid Viewer (00859873006189)November 8, 2024
K243186siemens medical solutions usaSymbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.speOctober 30, 2024
K241585shanghai united imaging healthcare couMI PanoramaAugust 30, 2024
K241596shanghai united imaging healthcare couMI PanvivoAugust 15, 2024
K241665ge medical systems israel, functional imagingOmni LegendAugust 8, 2024