System, X-Ray, Tomography, Computed
Regulation 892.1750
22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Top companies in JAK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2023 | K223804 | PercuNav Image Fusion and Interventional Navigation System Philips Ultrasound, LLC | JAK |
| Dec 22, 2022 | K223311 | Philips CT 3500 Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Dec 2, 2022 | K213465 | CardioGraphe Arineta , Ltd., IL | JAK |
| Oct 20, 2022 | K222361 | AI-Rad Companion (Musculoskeletal) Siemens Medical Solutions USA, Inc. | JAK |
| Sep 23, 2022 | K213759 | XACT Robotic System, ACE Model Xact Robotics, Ltd., IL | JAK |
| Sep 12, 2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE Canon Medical Systems Corporation, JP | JAK |
| Aug 11, 2022 | K220910 | Medical image processing software Hangzhou Deepwise & League of PHD Technology Co., Ltd., CN | JAK |
| Aug 11, 2022 | K213713 | AI-Rad Companion (Pulmonary) Siemens Healthcare GmbH | JAK |
| Jul 29, 2022 | K220961 | Deep Learning Image Reconstruction Ge Healthcare Japan Corporation, JP | JAK |
| Jul 13, 2022 | K221727 | syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. | JAK |
| Jul 12, 2022 | K220814 | NAEOTOM Alpha, Scan&GO Software Siemens Medical Solutions USA, Inc. | JAK |
| Jun 16, 2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation, JP | JAK |
| May 23, 2022 | K213829 | SCENARIA View Fujifilm Healthcare Corporation, JP | JAK |
| May 17, 2022 | K221219 | syngo.CT CaScoring Siemens Medical Solutions USA, Inc. | JAK |
| May 13, 2022 | K221116 | XACT ACE Robotic System Xact Robotics, Ltd., IL | JAK |
| May 13, 2022 | K212875 | Spectral CT on Rails Philips Medical Systems Nederland B.V., NL | JAK |
| May 6, 2022 | K220664 | NewTom 7G Cefla S.C., IT | JAK |
| May 2, 2022 | K211180 | Liver Suite GE Medical Systems SCS, FR | JAK |
| Apr 29, 2022 | K213649 | BodyTom 64 Neurologica Corporation | JAK |
| Apr 27, 2022 | K212441 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Apr 22, 2022 | K213944 | HealthOST Nanoxai , Ltd., IL | JAK |
| Mar 28, 2022 | K212889 | Syngo.CT Dual Energy Siemens Medical Solutions USA, Inc. | JAK |
| Mar 11, 2022 | K213725 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Mar 7, 2022 | K220450 | syngo.CT Applications Siemens Medical Solutions USA, Inc. | JAK |
| Feb 25, 2022 | K211711 | OmniTom Elite Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK |
| Feb 24, 2022 | K211645 | Epione Quantum Surgical Sas, FR | JAK |
| Feb 18, 2022 | K213999 | Deep Learning Image Reconstruction Ge Medical Systems, LLC | JAK |
| Feb 4, 2022 | K213938 | Revolution Ascend Ge Healthcare Japan Corporation, JP | JAK |
| Jan 20, 2022 | K214019 | syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. | JAK |
| Jan 14, 2022 | K213927 | Respiratory Gating for Scanners v2.0 Varian Medical Systems, Inc. | JAK |
| Jan 14, 2022 | K210760 | Precise Image Philips Medical Systems Nederland B.V., NL | JAK |
| Dec 17, 2021 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re Ge Medical Systems, LLC | JAK |
| Dec 6, 2021 | K213096 | Al-Rad Companion (Pulmonary) Siemens Medical Solutions USA, Inc. | JAK |
| Nov 22, 2021 | K211168 | Philips Incisive CT on Trailer Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Sep 30, 2021 | K211591 | NAEOTOM Alpha, Scan&GO Siemens Medical Solutions USA, Inc. | JAK |
| Sep 17, 2021 | K212067 | Deep Learning Image Reconstruction Ge Healthcare Japan Corporation, JP | JAK |
| Sep 15, 2021 | K210085 | HealthCCSng Zebra Medical Vision, Ltd., IL | JAK |
| Sep 10, 2021 | K211828 | Aquilion Exceed LB Canon Medical Systems Corporation, JP | JAK |
| Sep 2, 2021 | K212494 | Lung Image Analysis Pulmonx Corporation | JAK |
| Aug 27, 2021 | K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and Siemens Medical Solutions USA, Inc. | JAK |
| Aug 11, 2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Jul 22, 2021 | K203411 | syngo.CT Skull Unfolding Siemens Medical Solutions USA, Inc. | JAK |
| Jun 22, 2021 | K203720 | MICROMATE Isys Medizintechnik GmbH, AT | JAK |
| Jun 17, 2021 | K203514 | Precise Position Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Apr 30, 2021 | K203699 | syngo. CT Extended Functionalities Siemens Medical Solutions USA, Inc. | JAK |
| Mar 24, 2021 | K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System Canon Medical Systems Corporation, JP | JAK |
| Mar 2, 2021 | K203617 | MaxFOV 2 Ge Medical Systems, LLC | JAK |
| Feb 26, 2021 | K203020 | Spectral CT Philips Medical Systems Nederland B.V., NL | JAK |
| Feb 16, 2021 | K200626 | VesselIQ Xpress GE Medical Systems SCS, FR | JAK |
| Feb 2, 2021 | K201231 | CTxx85 CT Scanner Analogic Corporation | JAK |
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