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 |
|---|---|---|---|
| Jun 5, 2019 | K190505 | Low Dose Lung Screening Option Canon Medical Systems Corporation, JP | JAK |
| May 29, 2019 | K182716 | Brain Perfusion (BP) application Philips Medical Systems Nederland B.V., NL | JAK |
| Apr 15, 2019 | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 Siemens Medical Solutions USA, Inc. | JAK |
| Apr 12, 2019 | K183202 | Deep Learning Image Reconstruction Ge Medical Systems, LLC | JAK |
| Apr 8, 2019 | K183204 | Bone VCAR (BVCAR) GE Medical Systems SCS, FR | JAK |
| Mar 8, 2019 | K183448 | NewTom 5G XL Cefla S.C., IT | JAK |
| Feb 13, 2019 | K183161 | SnapShot Freeze 2 Ge Medical Systems, LLC | JAK |
| Feb 1, 2019 | K183291 | Supria True64 Whole-Body X-Ray CT System Hitachi Healthcare Americas | JAK |
| Jan 3, 2019 | K183143 | uCT 520, uCT 528 Shangai United Imaging Healthcare Co., Ltd., CN | JAK |
| Nov 16, 2018 | K181646 | Celesteion, PCA-9000A/3, V6.5 Canon Medical Systems Corporation, JP | JAK |
| Oct 4, 2018 | K173076 | CURA 16; ScintCare CT16 Fmi Medical Systems, Inc. | JAK |
| Sep 14, 2018 | K182223 | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A Canon Medical Systems, USA, JP | JAK |
| Sep 7, 2018 | K182147 | CTXX85 Analogic Corporation | JAK |
| Aug 14, 2018 | K181414 | uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Aug 3, 2018 | K181797 | Philips CT Big Bore Sliding Gantry Configuration Phillips Medical Systems (Cleveland), Inc. | JAK |
| Jun 13, 2018 | K172983 | HealthCCS Zebra Medical Vision, Ltd., IL | JAK |
| Jun 5, 2018 | K173821 | LungQ Software Thirona Corporation, NL | JAK |
| May 16, 2018 | K180901 | Low Dose CT Lung Cancer Screening Option Hitachi Healthcare Americas | JAK |
| May 11, 2018 | K180727 | LineUp Curvebeam, LLC | JAK |
| Apr 24, 2018 | K180225 | GSI Viewer with GSI Fat Option GE Medical Systems SCS, FR | JAK |
| Apr 24, 2018 | K162314 | IMACTIS CT-Navigation system Imactis, Sas, FR | JAK |
| Apr 13, 2018 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc. | JAK |
| Mar 30, 2018 | K173637 | syngo.CT Coronary Analysis; syngo.CT Vascular Analysis Siemens Medical Solutions USA, Inc. | JAK |
| Mar 30, 2018 | K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Dei Siemens Medical Solutions USA, Inc. | JAK |
| Mar 21, 2018 | K173607 | SOMATOM Edge Plus Siemens Medical Solutions USA, Inc. | JAK |
| Mar 20, 2018 | K180015 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Mar 15, 2018 | K180393 | AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC | JAK |
| Mar 8, 2018 | K173625 | syngo.CT Clinical Extensions Siemens Medical Solutions USA, Inc. | JAK |
| Mar 2, 2018 | K172135 | uCT Computed Tomography X-ray System Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Feb 23, 2018 | K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshibamedical Systems Corporation, JP | JAK |
| Feb 13, 2018 | K172058 | CT6485, CT12885 Analogic Corporation | JAK |
| Feb 8, 2018 | K173244 | superDimension Navigation System V7.2 Covidien, LLC | JAK |
| Jan 19, 2018 | K173478 | OnSight 3D Extremity System Carestream Health, Inc. | JAK |
| Dec 8, 2017 | K171677 | Clear Guide SCENERGY Clear Guide Medical | JAK |
| Dec 7, 2017 | K171198 | NeuViz 16 Essence Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., CN | JAK |
| Nov 22, 2017 | K172539 | CereTom Elite Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK |
| Nov 16, 2017 | K163643 | SIRIO H3 Masmec Spa, IT | JAK |
| Nov 9, 2017 | K171850 | Philips CT Big Bore Philips Medical Systems (Cleveland), Inc. | JAK |
| Oct 6, 2017 | K172188 | Aquilion Prime SP, TSX-303B/1, v8.4 Toshiba Medical Systems Coroporation, JP | JAK |
| Sep 13, 2017 | K171201 | NeuViz Prime Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., CN | JAK |
| Aug 18, 2017 | K171738 | Supria True64 Hitachi Healthcare Americas Corporation | JAK |
| Aug 18, 2017 | K171261 | ScannerSide DoseCheck Right Dose, Inc. | JAK |
| Aug 18, 2017 | K171183 | OmniTom Neurologica Corporation | JAK |
| Jun 30, 2017 | K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Toshibamedical Systems Corporation, JP | JAK |
| Jun 14, 2017 | K170238 | BodyTom Elite Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK |
| Jun 5, 2017 | K171013 | Revolution ACT Ge Hangwei Medical Systems Co., Ltd., CN | JAK |
| May 15, 2017 | K170023 | SPiN Thoracic Navigation System Veran Medical Technologies, Inc. | JAK |
| May 9, 2017 | K171022 | Ablation Confirmation Neuwave Medical, Inc. | JAK |
| May 5, 2017 | K170789 | In Reach Curvebeam, LLC | JAK |
| Apr 28, 2017 | K170273 | Z-DOSE29 Zetta Medical Technologies, LLC | JAK |
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