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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K181414 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K172135 |
| Jul 20, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036
Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce Open, Classified |
JAK | K181414 |
| Jul 15, 2020 | NeuroLogica Corporation OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for Terminated |
JAK | K171183 |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 530 Computed Tomography X-Ray System Open, Classified |
JAK | K181414 |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 760 System, Computed Tomography X-ray System Terminated |
JAK | K172135 |
| May 6, 2020 | Philips North America, LLC Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067 Terminated |
JAK | K193454 |
| May 6, 2020 | Philips North America, LLC Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 Terminated |
JAK | K060937 |
| May 6, 2020 | Philips North America, LLC Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848 Terminated |
JAK | K060937 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 Open, Classified |
JAK | K170177 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Precision, Model TSX-304A Open, Classified |
JAK | K173468 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime SP, Model TSX-303B Open, Classified |
JAK | K172188 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime, Model TSX-303A Open, Classified |
JAK | K120710 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One Vision, Model TSX-301C Open, Classified |
JAK | K151673 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Premium, Model TSX-301B Open, Classified |
JAK | K120546 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-301A Open, Classified |
JAK | K093891 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Lightning, Model TSX-036A Open, Classified |
JAK | K170019 |
| Oct 16, 2019 | Hitachi Medical Systems America Inc Hitachi Scenaria Whole-body X-ray CT System Terminated |
JAK | K101888 K150595 |
| Oct 7, 2019 | Siemens Medical Solutions USA, Inc Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner.
SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM
Definition Edge (Model #10590000 Terminated |
JAK | K103127 K121072 +4 |
| Sep 24, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top, Models 11061640 & 11061648-
a Computer tomography x-ray system Terminated |
JAK | K173632 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT
Model # 882446, computed tomography x-ray system Terminated |
JAK | K123599 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT
Model # 882456, computed tomography x-ray system Terminated |
JAK | K172406 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT
Model # 728332, computed tomography x-ray system Terminated |
JAK | K163711 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Brilliance 64
Model # 728231, computed tomography x-ray system Terminated |
JAK | K042293 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT SP
Model # 728311, computed tomography x-ray system Terminated |
JAK | K162838 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT,
Model # 728306, computed tomography x-ray system Terminated |
JAK | K162838 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core
Model # 728321, computed tomography x-ray system Terminated |
JAK | K160743 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128
Model # 728323, computed tomography x-ray system Terminated |
JAK | K160743 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity CT,
Model # 728326, computed tomography x-ray system Terminated |
JAK | K160743 |
| Aug 1, 2019 | Imactis Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear in Open, Classified |
JAK | K162314 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top;
Models #11061648
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top;
Models #11061640
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All;
Models #11061638
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All;
Models #11061630
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up;
Models ##11061628
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up;
Models #11061620
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission Terminated |
JAK | K173632 |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Now;
Models #11061610 & 11061618
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray Terminated |
JAK | K173632 |
| Jul 25, 2019 | Siemens Medical Solutions USA, Inc syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models:
SOMATOM Definition Edge-Model #10590000;
SOMATOM Definition AS Model #8098027;
SOMATOM Definition Flash Model Terminated |
JAK | K143400 K143401 +1 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d Terminated |
JAK | K133589 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | K173607 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmiss Terminated |
JAK | K162302 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d Terminated |
JAK | K161196 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tra Terminated |
JAK | K190578 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tran Terminated |
JAK | K120579 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmi Terminated |
JAK | K103127 |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top, Model No. 11061648
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image Terminated |
JAK | K173632 |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All, Model No. 11061638
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image Terminated |
JAK | K173632 |
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