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Panels › Radiology › Product code JAK · Class 2

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)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Aug 5, 2020Shanghai 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
JAKK181414
Aug 5, 2020Shanghai 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
JAKK181414
Jul 27, 2020Shanghai 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
JAKK181414
Jul 27, 2020Shanghai 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
JAKK181414
Jul 27, 2020Shanghai 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
JAKK172135
Jul 20, 2020Shanghai 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
JAKK181414
Jul 15, 2020NeuroLogica 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
JAKK171183
May 8, 2020Shanghai United Imaging Healthcare Co., Ltd.
uCT 530 Computed Tomography X-Ray System
Open, Classified
JAKK181414
May 8, 2020Shanghai United Imaging Healthcare Co., Ltd.
uCT 760 System, Computed Tomography X-ray System
Terminated
JAKK172135
May 6, 2020Philips North America, LLC
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Terminated
JAKK193454
May 6, 2020Philips North America, LLC
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Terminated
JAKK060937
May 6, 2020Philips North America, LLC
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Terminated
JAKK060937
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Open, Classified
JAKK170177
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion Precision, Model TSX-304A
Open, Classified
JAKK173468
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion Prime SP, Model TSX-303B
Open, Classified
JAKK172188
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion Prime, Model TSX-303A
Open, Classified
JAKK120710
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion One Vision, Model TSX-301C
Open, Classified
JAKK151673
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion Premium, Model TSX-301B
Open, Classified
JAKK120546
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion One, Model TSX-301A
Open, Classified
JAKK093891
Apr 10, 2020Canon Medical System, USA, INC.
Canon Aquilion Lightning, Model TSX-036A
Open, Classified
JAKK170019
Oct 16, 2019Hitachi Medical Systems America Inc
Hitachi Scenaria Whole-body X-ray CT System
Terminated
JAKK101888
K150595
Oct 7, 2019Siemens 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
JAKK103127
K121072 +4
Sep 24, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Terminated
JAKK173632
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Vereos PET/CT Model # 882446, computed tomography x-ray system
Terminated
JAKK123599
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Terminated
JAKK172406
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
IQon Spectral CT Model # 728332, computed tomography x-ray system
Terminated
JAKK163711
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Brilliance 64 Model # 728231, computed tomography x-ray system
Terminated
JAKK042293
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
iCT SP Model # 728311, computed tomography x-ray system
Terminated
JAKK162838
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
iCT, Model # 728306, computed tomography x-ray system
Terminated
JAKK162838
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Ingenuity Core Model # 728321, computed tomography x-ray system
Terminated
JAKK160743
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Terminated
JAKK160743
Aug 6, 2019Philips Medical Systems (Cleveland) Inc
Ingenuity CT, Model # 728326, computed tomography x-ray system
Terminated
JAKK160743
Aug 1, 2019Imactis
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
JAKK162314
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 31, 2019Siemens 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
JAKK173632
Jul 25, 2019Siemens 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
JAKK143400
K143401 +1
Jul 3, 2019Siemens 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
JAKK133589
Jul 3, 2019Siemens 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
JAKK173607
Jul 3, 2019Siemens 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
JAKK162302
Jul 3, 2019Siemens 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
JAKK161196
Jul 3, 2019Siemens 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
JAKK190578
Jul 3, 2019Siemens 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
JAKK120579
Jul 3, 2019Siemens 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
JAKK103127
Jun 4, 2019Siemens 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
JAKK173632
Jun 4, 2019Siemens 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
JAKK173632

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