| NewTom 5G XL (K183448) | Cefla S.C. | 2019-03-08 |
| SnapShot Freeze 2 (K183161) | Ge Medical Systems, LLC | 2019-02-13 |
| Supria True64 Whole-Body X-Ray CT System (K183291) | Hitachi Healthcare Americas | 2019-02-01 |
| uCT 520, uCT 528 (K183143) | Shangai United Imaging Healthcare Co., Ltd. | 2019-01-03 |
| Celesteion, PCA-9000A/3, V6.5 (K181646) | Canon Medical Systems Corporation | 2018-11-16 |
| CURA 16; ScintCare CT16 (K173076) | Fmi Medical Systems, Inc. | 2018-10-04 |
| Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A (K182223) | Canon Medical Systems, USA | 2018-09-14 |
| CTXX85 (K182147) | Analogic Corporation | 2018-09-07 |
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |
| Philips CT Big Bore Sliding Gantry Configuration (K181797) | Phillips Medical Systems (Cleveland), Inc. | 2018-08-03 |
| HealthCCS (K172983) | Zebra Medical Vision, Ltd. | 2018-06-13 |
| LungQ Software (K173821) | Thirona Corporation | 2018-06-05 |
| Low Dose CT Lung Cancer Screening Option (K180901) | Hitachi Healthcare Americas | 2018-05-16 |
| LineUp (K180727) | Curvebeam, LLC | 2018-05-11 |
| IMACTIS CT-Navigation system (K162314) | Imactis, Sas | 2018-04-24 |
| GSI Viewer with GSI Fat Option (K180225) | GE Medical Systems SCS | 2018-04-24 |
| SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO (K173632) | Siemens Medical Solutions USA, Inc. | 2018-04-13 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence (K173630) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| syngo.CT Coronary Analysis; syngo.CT Vascular Analysis (K173637) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| SOMATOM Edge Plus (K173607) | Siemens Medical Solutions USA, Inc. | 2018-03-21 |
| Philips Incisive CT (K180015) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 |
| AIRO Computed Tomography (CT) X-ray System (K180393) | Mobius Imaging, LLC | 2018-03-15 |
| syngo.CT Clinical Extensions (K173625) | Siemens Medical Solutions USA, Inc. | 2018-03-08 |
| uCT Computed Tomography X-ray System (K172135) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-03-02 |
| Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 (K173468) | Toshibamedical Systems Corporation | 2018-02-23 |
| CT6485, CT12885 (K172058) | Analogic Corporation | 2018-02-13 |
| superDimension Navigation System V7.2 (K173244) | Covidien, LLC | 2018-02-08 |
| OnSight 3D Extremity System (K173478) | Carestream Health, Inc. | 2018-01-19 |
| Clear Guide SCENERGY (K171677) | Clear Guide Medical | 2017-12-08 |
| NeuViz 16 Essence Multi-slice CT Scanner System (K171198) | Neusoft Medical Systems Co., Ltd. | 2017-12-07 |
| CereTom Elite (K172539) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-11-22 |
| SIRIO H3 (K163643) | Masmec Spa | 2017-11-16 |
| Philips CT Big Bore (K171850) | Philips Medical Systems (Cleveland), Inc. | 2017-11-09 |
| Aquilion Prime SP, TSX-303B/1, v8.4 (K172188) | Toshiba Medical Systems Coroporation | 2017-10-06 |
| NeuViz Prime Multi-slice CT Scanner System (K171201) | Neusoft Medical Systems Co., Ltd. | 2017-09-13 |
| ScannerSide DoseCheck (K171261) | Right Dose, Inc. | 2017-08-18 |
| Supria True64 (K171738) | Hitachi Healthcare Americas Corporation | 2017-08-18 |
| OmniTom (K171183) | Neurologica Corporation | 2017-08-18 |
| Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 (K170177) | Toshibamedical Systems Corporation | 2017-06-30 |
| BodyTom Elite (K170238) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-06-14 |
| Revolution ACT (K171013) | Ge Hangwei Medical Systems Co., Ltd. | 2017-06-05 |
| SPiN Thoracic Navigation System (K170023) | Veran Medical Technologies, Inc. | 2017-05-15 |
| Ablation Confirmation (K171022) | Neuwave Medical, Inc. | 2017-05-09 |
| In Reach (K170789) | Curvebeam, LLC | 2017-05-05 |
| Z-DOSE29 (K170273) | Zetta Medical Technologies, LLC | 2017-04-28 |
| syngo.CT Cardiac Planning (K170221) | Siemens Healthcare GmbH | 2017-04-21 |
| PercuNav Image Fusion and Interventional Navigation (K170716) | Philips Ultrasound, Inc. | 2017-04-21 |
| Philips iCT CT System (K162838) | Philips Medical Systems (Cleveland), Inc. | 2017-04-07 |
| IQon Spectral CT (K163711) | Philips Medical Systems (Cleveland), Inc. | 2017-04-05 |
| Scan&GO (K163297) | Siemens Medical Solutions USA, Inc. | 2017-03-24 |
| SOMATOM go.Up, SOMATOM go.Now (K163296) | Siemens Medical Solutions USA, Inc. | 2017-03-21 |
| HITACHI Supria Whole-body X-ray CT System Phase 3 (K163528) | Hitachi Medical Systems America, Inc. | 2017-03-03 |
| syngo. CT Neuro Perfusion (K163284) | Siemens Medical Solutions USA, Inc. | 2017-03-01 |
| syngo.CT Extended Functionality (K163341) | Siemens Medical Solutions USA, Inc. | 2017-02-09 |
| syngo. CT Single Source Dual Energy (twin beam) (K163289) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2017-02-09 |
| Aquilion Lightning, TSX-036A/1, V8.4 (K170019) | Toshibamedical Systems Corporation | 2017-02-02 |
| FastStroke (K163281) | Gef Medical Systems Scs | 2017-01-26 |
| Revolution CT (K163213) | Ge Medical Systems, LLC | 2016-12-16 |
| Somatom Confidence ® RT Pro (K162302) | Siemens Medical Solutions USA, Inc. | 2016-12-16 |
| Vitrea CT Dual Energy Image View (K161157) | Vital Images, Inc. | 2016-11-03 |
| OnSight 3D Extremity System (K160723) | Carestream Health, Inc. | 2016-08-30 |
| SOMATOM Drive (K161196) | Siemens Medical Solutions USA, Inc. | 2016-08-24 |
| SUPRIA w/guideShot Option (K161748) | Hitachi Medical Systems America, Inc. | 2016-08-17 |
| SpotLight CT (K161066) | Arineta , Ltd. | 2016-08-10 |
| P-ARTIS (K160611) | P-Cure, Ltd. | 2016-08-08 |
| Philips Ingenuity CT (K160743) | Philips Medical Systems (Cleveland), Inc. | 2016-08-08 |
| Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 (K161009) | Toshibamedical Systems Corporation | 2016-07-22 |
| ADMIRE (K153360) | Siemens Medi Cal Solutions, Inc. | 2016-06-29 |
| Ablation Confirmation (K161285) | Neuwave Medical, Inc. | 2016-06-29 |
| ECG CT Gating Device (K160350) | Neocoil, LLC | 2016-06-16 |
| Aquilion ONE (TSX-305A/3) V7.3 (K160587) | Toshibamedical Systems Corporation | 2016-06-09 |
| SafeCT-29 (K153331) | Medic Vision Imaging Solutions | 2016-05-17 |
| AIRO Computed Tomography (CT) X-ray System (K160126) | Mobius Imaging | 2016-04-19 |
| Philips Multislice CT System with Low Dose CT Lung Cancer (K153444) | Philips Medical Systems (Cleveland), Inc. | 2016-04-08 |
| Aquilion Lightning, TSX-035A/4 and /5, V7.0 (K153263) | Toshibamedical Systems Corporation | 2016-04-01 |
| SOMATOM Perspective (K151765) | Siemens Medical Solutions USA, Inc. | 2016-03-25 |
| somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) (K151749) | Siemens Medical Solutions USA, Inc. | 2016-03-18 |
| SmartView 3D Option (K153429) | Ge Hangwei Medical System Co., Ltd. | 2016-03-09 |
| syngo.CT Single Source Dual Energy (Twin Beam) (K153220) | Siemens Medical Solutions USA, Inc. | 2016-02-19 |
| Clear Guide SCENERGY (K153004) | Clear Guide Medical | 2016-02-12 |
| CAS-One IR (K152473) | Cascination AG | 2016-01-20 |
| Stroke VCAR (K152584) | GE Medical Systems SCS | 2016-01-20 |
| Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (K151673) | Toshibamedical Systems Corporation | 2015-11-27 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (K142955) | Siemens Medical Solutions USA, Inc. | 2015-11-24 |
| IQQA Guide (K151414) | Edda Technology | 2015-11-20 |
| SOMATOM Emotion 6/16 (K151752) | Siemens Medical Solutions USA, Inc. | 2015-11-12 |
| superDimension Navigation System (K151376) | Covidien, LLC | 2015-11-05 |
| NeuViz 128 Multi-slice CT Scanner System (K151383) | Neusoft Medical Systems Co., Ltd. | 2015-11-04 |
| syngo.CT Myocardial Perfusion (K150713) | Siemens Medical Solutions USA, Inc. | 2015-11-02 |
| SCENARIA Phase 3 Whole-body X-ray CT System (K150595) | Hitachi Medical Systems America, Inc. | 2015-10-30 |
| Lung Analysis Software (K151283) | Vital Images, Inc. | 2015-10-30 |
| Vitrea CT Lung Density Analysis Software (K151919) | Vital Images, Inc. | 2015-10-10 |
| SOMATOM Definition Edge, SOMATOM Definition AS/AS+ (K152036) | Siemens Medical Solutions USA, Inc. | 2015-10-09 |
| Aquilion Lightning (TSX-035A/2, V7.0) (K151833) | Toshibamedical Systems Corporation | 2015-10-09 |
| Supria Whole-body X-ray CT System (K150565) | Hitachi Medical Systems America, Inc. | 2015-09-30 |
| Low Dose CT Lung Cancer Screening Option for Qualified GE Systems (K151372) | Ge Medical Systems, LLC | 2015-08-14 |
| Respiratory Gating for Scanners (K151533) | Varian Medical Systems, Inc. | 2015-08-13 |
| syngo.CT Single Source Dual Energy (K150745) | Siemens Medical Solutions USA, Inc. | 2015-08-11 |
| syngo.CT Dual Energy (K150757) | Siemens Medical Solutions USA, Inc. | 2015-08-11 |
| Philips Spectral CT Applications (K150665) | Philips Medical Systems Nethrlands BV | 2015-08-07 |