| Aquilion Precision (TSX-304A/4) V10.10 with AiCE (K220986) | Canon Medical Systems Corporation | 2022-09-12 |
| AI-Rad Companion (Pulmonary) (K213713) | Siemens Healthcare GmbH | 2022-08-11 |
| Medical image processing software (K220910) | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | 2022-08-11 |
| Deep Learning Image Reconstruction (K220961) | Ge Healthcare Japan Corporation | 2022-07-29 |
| syngo.CT Extended Functionality (K221727) | Siemens Medical Solutions USA, Inc. | 2022-07-13 |
| NAEOTOM Alpha, Scan&GO Software (K220814) | Siemens Medical Solutions USA, Inc. | 2022-07-12 |
| Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (K213504) | Canon Medical Systems Corporation | 2022-06-16 |
| SCENARIA View (K213829) | Fujifilm Healthcare Corporation | 2022-05-23 |
| syngo.CT CaScoring (K221219) | Siemens Medical Solutions USA, Inc. | 2022-05-17 |
| XACT ACE Robotic System (K221116) | Xact Robotics, Ltd. | 2022-05-13 |
| Spectral CT on Rails (K212875) | Philips Medical Systems Nederland B.V. | 2022-05-13 |
| NewTom 7G (K220664) | Cefla S.C. | 2022-05-06 |
| Liver Suite (K211180) | GE Medical Systems SCS | 2022-05-02 |
| BodyTom 64 (K213649) | Neurologica Corporation | 2022-04-29 |
| Philips Incisive CT (K212441) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 |
| HealthOST (K213944) | Nanoxai , Ltd. | 2022-04-22 |
| Syngo.CT Dual Energy (K212889) | Siemens Medical Solutions USA, Inc. | 2022-03-28 |
| CardIQ Suite (K213725) | GE Medical Systems SCS | 2022-03-11 |
| syngo.CT Applications (K220450) | Siemens Medical Solutions USA, Inc. | 2022-03-07 |
| OmniTom Elite (K211711) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2022-02-25 |
| Epione (K211645) | Quantum Surgical Sas | 2022-02-24 |
| Deep Learning Image Reconstruction (K213999) | Ge Medical Systems, LLC | 2022-02-18 |
| Revolution Ascend (K213938) | Ge Healthcare Japan Corporation | 2022-02-04 |
| syngo.CT Extended Functionality (K214019) | Siemens Medical Solutions USA, Inc. | 2022-01-20 |
| Respiratory Gating for Scanners v2.0 (K213927) | Varian Medical Systems, Inc. | 2022-01-14 |
| Precise Image (K210760) | Philips Medical Systems Nederland B.V. | 2022-01-14 |
| Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition (K213715) | Ge Medical Systems, LLC | 2021-12-17 |
| Al-Rad Companion (Pulmonary) (K213096) | Siemens Medical Solutions USA, Inc. | 2021-12-06 |
| Philips Incisive CT on Trailer (K211168) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 |
| NAEOTOM Alpha, Scan&GO (K211591) | Siemens Medical Solutions USA, Inc. | 2021-09-30 |
| Deep Learning Image Reconstruction (K212067) | Ge Healthcare Japan Corporation | 2021-09-17 |
| HealthCCSng (K210085) | Zebra Medical Vision, Ltd. | 2021-09-15 |
| Aquilion Exceed LB (K211828) | Canon Medical Systems Corporation | 2021-09-10 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software (K211373) | Siemens Medical Solutions USA, Inc. | 2021-08-27 |
| uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 |
| syngo.CT Skull Unfolding (K203411) | Siemens Medical Solutions USA, Inc. | 2021-07-22 |
| MICROMATE (K203720) | Isys Medizintechnik GmbH | 2021-06-22 |
| Precise Position (K203514) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-06-17 |
| syngo. CT Extended Functionalities (K203699) | Siemens Medical Solutions USA, Inc. | 2021-04-30 |
| Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (K203225) | Canon Medical Systems Corporation | 2021-03-24 |
| MaxFOV 2 (K203617) | Ge Medical Systems, LLC | 2021-03-02 |
| Spectral CT (K203020) | Philips Medical Systems Nederland B.V. | 2021-02-26 |
| VesselIQ Xpress (K200626) | GE Medical Systems SCS | 2021-02-16 |
| CTxx85 CT Scanner (K201231) | Analogic Corporation | 2021-02-02 |
| Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836) | Canon Medical Systems Corporation | 2021-01-12 |
| OmniTom Elite (K202526) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 |
| Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I (K203042) | Canon Medical Systems Corporation | 2020-12-10 |
| Deep Learning Image Reconstruction for Gemstone Spectral Imaging (K201745) | Ge Medical Systems, LLC | 2020-12-10 |
| The Multimodality Advanced Vessel Analysis (K203216) | Philips Medical Systems Nederland B.V. | 2020-11-25 |
| Revolution Ascend (K203169) | Ge Healthcare Japan Corporation | 2020-11-20 |
| HiRise (K203187) | Curvebeam, LLC | 2020-11-18 |
| FastStroke, CT Perfusion 4D (K193289) | GE Medical Systems SCS | 2020-11-12 |
| LSN (K201092) | Imaging Biometrics, LLC | 2020-10-29 |
| syngo.CT Neuro Perfusion (K202213) | Siemens Medical Solutions USA, Inc. | 2020-10-11 |
| Clear Guide SCENERGY (K201188) | Clear Guide Medical | 2020-09-30 |
| VIDAvision (K200990) | Vida Diagnostics, Inc. | 2020-08-07 |
| Clear Guide SCENERGY (K201898) | Clear Guide Medical | 2020-07-31 |
| SOMATOM On.site and On.scene (K193277) | Siemens Medical Solutions USA, Inc. | 2020-07-22 |
| SCENARIA View (K200498) | Hitachi Healthcare Americas | 2020-07-17 |
| XACT Robotic System (K201586) | Xact Robotics, Ltd. | 2020-07-09 |
| Deep Recon (K193073) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 |
| Syngo.CT CaScoring (K201034) | Siemens Medical Solutions USA, Inc. | 2020-05-14 |
| XV Lung Ventilation Analysis Software (K193293) | 4Dx Limited | 2020-05-14 |
| PercuNav Image Fusion and Interventional Navigation (K201053) | Philips Ultrasound, Inc. | 2020-05-14 |
| SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO (K200524) | Siemens Medical Solutions USA, Inc. | 2020-04-01 |
| syngo.CT Cardiac Planning (K200515) | Siemens Medical Soultions USA, Inc. | 2020-03-25 |
| Hepatic VCAR (K193281) | GE Medical Systems SCS | 2020-03-20 |
| Al-Rad Companion (Musculoskeletal) (K193267) | Siemens Medical Solutions USA, Inc. | 2020-03-16 |
| CURA 778 (K192590) | Fmi Medical Systems, Inc. | 2020-03-05 |
| Broncholab (K191550) | Fluidda, Inc. | 2020-03-04 |
| uCT 530, uCT 550 (K200016) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-02-25 |
| Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (K192832) | Canon Medical Systems Corporation | 2020-02-21 |
| Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (K192828) | Canon Medical Systems Corporation | 2020-02-13 |
| IQon Spectral CT (K193454) | Philips Medical Systems Nederland B.V. | 2020-01-24 |
| Auto Positioning (K192956) | Ge Hangwei Medical Systems Co., Ltd. | 2020-01-16 |
| syngo.CT CaScoring (K192763) | Siemens Medical Solutions USA, Inc. | 2019-12-17 |
| Deep Learning Image Reconstruction (K193170) | Ge Healthcare Japan Corporation | 2019-12-13 |
| SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO (K192061) | Siemens Medical Solutions USA, Inc. | 2019-11-21 |
| SOMATOM X.cite (K191891) | Siemens Medical Solutions USA, Inc. | 2019-11-06 |
| Revolution Maxima, Revolution Ace (K192686) | Ge Hangwei Medical Systems Co., Ltd. | 2019-10-24 |
| XACT Robotic System (K191332) | Xact Robotics, Ltd. | 2019-10-03 |
| Ablation Confirmation (K192427) | Neuwave Medical, Inc. | 2019-10-03 |
| syngo.CT Extended Functionality (K192402) | Siemens Medical Solutions USA, Inc. | 2019-09-20 |
| SCENARIA View (K190841) | Hitachi Healthcare Americas | 2019-09-13 |
| AI-Rad Companion (Cardiovascular) (K183268) | Siemens Medical Solutions USA, Inc. | 2019-09-10 |
| Aquilion ONE (TSX-306A/3) V10.0 (K192188) | Canon Medical Systems Corporation | 2019-09-06 |
| ILLUMISITE Platform (K191394) | Covidien, LLC | 2019-08-07 |
| Access CT (K191136) | Philips Healthcare (Suzhou) Co., Ltd. | 2019-07-29 |
| Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777) | Ge Medical Systems, LLC | 2019-07-26 |
| AI-Rad Companion (Pulmonary) (K183271) | Siemens Medical Solutions USA, Inc. | 2019-07-26 |
| Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (K182901) | Canon Medical Systems Corporation | 2019-07-05 |
| syngo.CT Dual Energy (K191468) | Siemens Medical Solutions USA, Inc. | 2019-07-03 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (K190578) | Siemens Medical Solutions USA, Inc. | 2019-06-27 |
| Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046) | Canon Medical Systems Corporation | 2019-06-12 |
| Low Dose Lung Screening Option (K190505) | Canon Medical Systems Corporation | 2019-06-05 |
| Brain Perfusion (BP) application (K182716) | Philips Medical Systems Nederland B.V. | 2019-05-29 |
| SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 (K183548) | Siemens Medical Solutions USA, Inc. | 2019-04-15 |
| Deep Learning Image Reconstruction (K183202) | Ge Medical Systems, LLC | 2019-04-12 |
| Bone VCAR (BVCAR) (K183204) | GE Medical Systems SCS | 2019-04-08 |