| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
| Bunkerhill Contrast CAC (K260166) | BunkerHill Health | 2026-03-06 |
| Bunkerhill Contrast AVC (K260167) | BunkerHill Health | 2026-03-06 |
| AV Cardiac CT (K260169) | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| uCT 780 with uWS-CT-Dual Energy Analysis (K253173) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| CT VScore+ (K252217) | Canon Medical Informatics, Inc. | 2025-11-28 |
| syngo.CT Dual Energy (K251805) | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| Bunkerhill MAC (K250662) | BunkerHill Health | 2025-10-03 |
| LungQ 4 (K250766) | Thirona BV | 2025-10-02 |
| Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (K251645) | Canon Medical Systems Corporation | 2025-09-26 |
| OmniTom Elite with PCD (K250928) | Neurologica Corporation | 2025-09-08 |
| CT:VQ (K251484) | 4Dmedical Limited | 2025-08-28 |
| Revolution Vibe (K250941) | Ge Medical Systems, LLC | 2025-08-01 |
| NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K251061) | Siemens Medical Solutions USA, Inc. | 2025-07-28 |
| Marie (K250970) | Leo Cancer Care | 2025-07-25 |
| SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse (K250822) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Philips iCT CT system (K250648) | Philips Medical Systems Nederland B.V. | 2025-06-27 |
| CT Scanner TSX-501R/1 V11.1 (K243398) | Canon Medical Systems Corporation | 2025-06-20 |
| CardIQ Suite (K243672) | GE Medical Systems SCS | 2025-06-18 |
| SCENARIA View Phase 5.0 (K250370) | Fujifilm Corporation | 2025-05-20 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (K243617) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 |
| Spectral CT (K244008) | Philips Medical Systems Technologies , Ltd. | 2025-05-16 |
| SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (K250650) | Arineta , Ltd. | 2025-04-15 |
| Vitrea CT VScore (K243240) | Canon Medical Informatics, Inc. | 2025-04-10 |
| BodyTom 64 (K242811) | Neurologica Corporation, A Subsidiary of Samsung | 2025-03-14 |
| Brainomix 360 e-Lung (K242411) | Brainomix Limited | 2025-02-19 |
| NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K243523) | Siemens Medical Solutions USA, Inc. | 2025-02-12 |
| Bunkerhill AVC (K243229) | BunkerHill Health | 2025-01-27 |
| uCT 550 (K241166) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 |
| SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200) | Arineta , Ltd. | 2025-01-13 |
| uCT 780 (K241079) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 |
| syngo.CT Dual Energy (K241757) | Siemens Medical Solutions USA, Inc. | 2025-01-03 |
| Aquilion ONE (TSX-308A/3) V1.5 (K242403) | Canon Medical Systems Corporation | 2024-12-23 |
| ClearRead CT CAC (K242188) | Riverain Technologies, Inc. | 2024-12-03 |
| Gating Reflector Block (K242874) | Varian Medical Systems, Inc. | 2024-11-21 |
| Spectral CT 7500 RT (K240844) | Philips Medical Systems Technologies , Ltd. | 2024-10-18 |
| CAC (gated) Algorithm (K240369) | BunkerHill Health | 2024-09-27 |
| SOMATOM On.site (K241295) | Siemens Medical Solutions USA, Inc. | 2024-09-03 |
| HealthCCSng (K241440) | Nano-X AI , Ltd. | 2024-08-19 |
| CardIQ Suite (K233731) | GE Medical Systems SCS | 2024-08-01 |
| HiRise (1040-230) (K241713) | Curvebeam, LLC | 2024-07-12 |
| OmniTom Elite (K233767) | Neurologica Corporation | 2024-06-10 |
| Brainomix 360 e-Lung (K233875) | Brainomix Limited | 2024-05-13 |
| CT 5300 (K232491) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-05-03 |
| FCT iSTREAM Phase 1 (K233583) | FUJIFILM Healthcare Americas Corporation | 2024-04-26 |
| True Enhance DL (K233698) | Ge Healthcare Japan Corporation | 2024-04-11 |
| ABLATE-IQ (K232227) | Neuwave Medical, Inc. | 2024-04-04 |
| ECG-less Cardiac (K233750) | Ge Medical Systems, LLC | 2024-04-02 |
| Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (K232835) | Canon Medical Systems Corporation | 2024-04-02 |
| NAEOTOM Alpha (K233657) | Siemens Medical Solutions USA, Inc. | 2024-03-28 |
| SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed (K233650) | Siemens Medical Solutions USA, Inc. | 2024-03-26 |
| AI-Rad Companion (Pulmonary) (K233753) | Siemens Healthcare GmbH | 2024-03-21 |
| CAS-One IR (K232022) | Cascination AG | 2024-03-13 |
| Revolution Ascend Sliding (K233749) | Ge Hangwei Medical Systems Co., Ltd. | 2024-02-22 |
| HealthFLD (K233080) | Nano-X AI , Ltd. | 2024-02-08 |
| Clear Guide SCENERGY (K234030) | Clear Guide Medical | 2024-01-17 |
| LungQ v3.0.0 (K232412) | Thirona BV | 2024-01-08 |
| syngo.CT Applications (K232136) | Siemens Medical Solutions USA, Inc. | 2024-01-04 |
| SOMATOM Pro.Pulse (K232206) | Siemens Medical Solutions USA, Inc. | 2023-12-06 |
| Aquilion Serve SP (TSX-307B/1) V1.3 (K233334) | Canon Medical Systems Corporation | 2023-12-06 |
| syngo.CT Dual Energy (K232155) | Siemens Medical Solutions USA, Inc. | 2023-11-30 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis (K231482) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 |
| BriefCase-Quantification (K231631) | Aidoc Medical , Ltd. | 2023-11-28 |
| CT Lung Ventilation Analysis Software (CT:V) (K232392) | 4Dmedical Limited | 2023-11-16 |
| MeVis Liver Suite (K232045) | MeVis Medical Solutions AG | 2023-10-27 |
| SpotLight/SpotLight Duo (with DLIR option) (K230370) | Arineta , Ltd. | 2023-10-13 |
| Scenaria View 4.2 (K231574) | FUJIFILM Healthcare Americas Corporation | 2023-10-12 |
| NeuViz 128 Multi-Slice CT Scanner System (K230220) | Neusoft Medical Systems Co., Ltd. | 2023-10-11 |
| Micromate™ Navi+ (K230130) | Isys Medizintechnik GmbH | 2023-10-10 |
| Aquilion Serve (TSX-307A/1) V1.3 (K231281) | Canon Medical Systems Corporation | 2023-09-19 |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (K230162) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 |
| Spine Auto Views (K223424) | GE Medical Systems SCS | 2023-07-13 |
| Open Rib (K223261) | Canon Medical Informatics, Inc. | 2023-07-13 |
| SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash (K230421) | Siemens Medical Solutions USA, Inc. | 2023-06-16 |
| CAC Software (K230112) | Imbio, Inc. | 2023-06-13 |
| OmniTom Elite (K223447) | Neurologica Corporation, A Subsidiary of Samsung | 2023-06-01 |
| Epione (K223758) | Quantum Surgical Sas | 2023-05-03 |
| iCAC Device (K230223) | Bunkerhill, Inc. | 2023-04-25 |
| Deep Learning Image Reconstruction (K230807) | Ge Healthcare Japan Corporation | 2023-04-20 |
| AI-Rad Companion (Cardiovascular) (K222360) | Siemens Medical Solutions U.S.A. | 2023-04-06 |
| Spectral Bone Marrow (K223514) | Ge Medical Systems, LLC | 2023-03-09 |
| Aquilion Precision (TSX-304A/4) V10.14 with AiCE (K223726) | Canon Medical Systems Corporation | 2023-03-07 |
| Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819) | Canon Medical Systems Corporation | 2023-03-03 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (K223028) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-02-16 |
| PercuNav Image Fusion and Interventional Navigation System (K223804) | Philips Ultrasound, LLC | 2023-01-18 |
| Philips CT 3500 (K223311) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-12-22 |
| CardioGraphe (K213465) | Arineta , Ltd. | 2022-12-02 |
| AI-Rad Companion (Musculoskeletal) (K222361) | Siemens Medical Solutions USA, Inc. | 2022-10-20 |
| XACT Robotic System, ACE Model (K213759) | Xact Robotics, Ltd. | 2022-09-23 |