ClearanceBrief
Panels › Radiology › Product code KPS · Class 2

System, Tomography, Computed, Emission

Regulation 892.1200

9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
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Top companies in KPS

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.46137
Philips Medical Systems (Cleveland), Inc.20110
GE Healthcare1275
Ge Medical Systems Israel, Functional Imaging239
GE Medical Systems2713
Adac Laboratories350
Shanghai United Imaging Healthcare Co., Ltd.1814
Philips Medical Systems028
Cti Pet Systems, Inc.184
Trionix Research Laboratory, Inc.161
Decided510(k)Device and applicantCode
Aug 6, 2021K211764Vereos PET/CT
Philips Medical Systems Nederland B.V., NL
KPS
Jul 27, 2021K211247PET VCAR
GE Medical Systems SCS, FR
KPS
May 19, 2021K210880Vereos PET/CT
Philips Medical Systems Nederland B.V., NL
KPS
May 12, 2021K210557Symbia VA10A Family
Siemens Medical Solutions USA, Inc.
KPS
Apr 30, 2021K210001HYPER AiR
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Apr 23, 2021K203314Cartesion Prime (PCD-1000A/3) V10.8
Canon Medical Systems Corporation, JP
KPS
Apr 12, 2021K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
Mcgovern Medical School
KPS
Apr 9, 2021K210418HYPER Focus
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Mar 29, 2021K210173StarGuide
GE Healthcare, IL
KPS
Mar 17, 2021K210450BBX-PET Scanner
Prescient Imaging, LLC
KPS
Mar 3, 2021K210262Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc.
KPS
Dec 23, 2020K202882Affinity
Hermes Medical Solutions AB, SE
KPS
Oct 23, 2020K202392SIR-Spheres Microspheres Activity Calculator (SMAC)
Sirtex Medical US Holdings, Inc.
KPS
Oct 15, 2020K202349Cartesion Prime, PCD-1000A, V10.7
Canon Medical Systems Corporation, JP
KPS
Aug 27, 2020K201807ANCORIS
Miegmbh, DE
KPS
Aug 11, 2020K201933ImagenSPECT 3.0
Cardiovascular Imaging Technologies
KPS
Aug 4, 2020K193210HYPER DLR
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Mar 20, 2020K200474Symbia 6.7
Siemens Medical Solutions USA, Inc.
KPS
Feb 14, 2020K193248Biograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, Inc.
KPS
Feb 14, 2020K193152Affinity
Hermes Medical Solutions AB, SE
KPS
Feb 14, 2020K192277CardIQ Flow
GE Medical Systems SCS, FR
KPS
Feb 12, 2020K193178Biograph Horizon
Siemens Medical Solution USA, Inc.
KPS
Jan 26, 2020K193241Emission Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Aug 13, 2019K191582Cartesion Prime
Canon Medical Systems Corporation, JP
KPS
Jul 12, 2019K190457VERITON CT whole body SPECT/CT system
Spectrum Dynamics Medical, Ltd., IL
KPS
May 6, 2019K190900Biograph Vision
Siemens Medical Solutions USA, Inc.
KPS
Dec 18, 2018K182938Emission Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Nov 30, 2018K182336SubtlePET
Subtle Medical, Inc.
KPS
Nov 9, 2018K182484VERITON CT whole body SPECT/CT system
Spectrum Dynamics Medical, Ltd., IL
KPS
Oct 25, 2018K181468Hybrid3D
Hermes Medical Solutions AB, SE
KPS
Oct 12, 2018K182237uMI 550 PET/CT System
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Aug 16, 2018K180077NeuroQ 3.8
Syntermed
KPS
Jun 12, 2018K181343HeartSee Cardiac P.E.T. Processing Software
Bracco Diagnostics, Inc.
KPS
May 23, 2018K180811Biograph Vision
Siemens Medical Solutions USA, Inc.
KPS
Apr 25, 2018K180514VERITON NM
Spectrum Dynamics Medical, Ltd., IL
KPS
Apr 17, 2018K173816NM/CT 850, NM/CT 860
GE Healthcare, IL
KPS
Apr 13, 2018K172143uMI 780 PET/CT System
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Apr 11, 2018K180318PET Digital Gating
Ge Medical Systems, LLC
KPS
Jan 12, 2018K173547ImagenUniversal
Cardiovascular Imaging Technologies
KPS
Dec 20, 2017K173578Biograph mCT Family of PET/CT Systems
Siemens Medical Solutions USA, Inc.
KPS
Nov 21, 2017K171719Hybrid3D
Hermes Medical Solutions AB, SE
KPS
Nov 21, 2017K171681Hermes Medical Imaging Suite v5.7
Hermes Medical Solutions AB, SE
KPS
Nov 17, 2017K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
Siemens Medical Solutions USA, Inc.
KPS
Nov 3, 2017K172609CSMC Cardiac Suite
Cedars-Sinai Medical Center
KPS
Oct 6, 2017K172406Ingenuity TF
Philips Medical Systems (Cleveland), Inc.
KPS
Sep 22, 2017K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
University of Texas Medical School AT Houston, Texas
KPS
Jun 1, 2017K170904Biograph Horizon PET/CT
Siemens Medical Solutions USA, Inc.
KPS
Jun 1, 2017K170490Celesteion, PCA-9000A/3
Toshibamedical Systems Corporation, JP
KPS
May 22, 2017K163394Hybrid3D
Hermes Medical Solutions AB, SE
KPS
Jan 9, 2017K162483Symbia Intevo Bold
Siemens Medical Solutions USA, Inc.
KPS

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