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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

Company510(k)sRecalls
Philips Medical Systems (Cleveland), Inc.24282
Siemens AG Medical Solutions117162
GE Healthcare796
GE Medical Systems6829
Philips North America064
Toshiba American Medical Systems Inc040
Toshiba America Medical Systems, In.C350
General Electric Co.310
Shanghai United Imaging Healthcare Co., Ltd.1216
Toshibamedical Systems Corporation270
Decided510(k)Device and applicantCode
Nov 21, 2024K242874Gating Reflector Block
Varian Medical Systems, Inc.
JAK
Oct 18, 2024K240844Spectral CT 7500 RT
Philips Medical Systems Technologies , Ltd., IL
JAK
Sep 27, 2024K240369CAC (gated) Algorithm
BunkerHill Health
JAK
Sep 3, 2024K241295SOMATOM On.site
Siemens Medical Solutions USA, Inc.
JAK
Aug 19, 2024K241440HealthCCSng
Nano-X AI , Ltd., IL
JAK
Aug 1, 2024K233731CardIQ Suite
GE Medical Systems SCS, FR
JAK
Jul 12, 2024K241713HiRise (1040-230)
Curvebeam, LLC
JAK
Jun 10, 2024K233767OmniTom Elite
Neurologica Corporation
JAK
May 13, 2024K233875Brainomix 360 e-Lung
Brainomix Limited, GB
JAK
May 3, 2024K232491CT 5300
Philips Healthcare (Suzhou) Co., Ltd., CN
JAK
Apr 26, 2024K233583FCT iSTREAM Phase 1
FUJIFILM Healthcare Americas Corporation
JAK
Apr 11, 2024K233698True Enhance DL
Ge Healthcare Japan Corporation, JP
JAK
Apr 4, 2024K232227ABLATE-IQ
Neuwave Medical, Inc.
JAK
Apr 2, 2024K233750ECG-less Cardiac
Ge Medical Systems, LLC
JAK
Apr 2, 2024K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation, JP
JAK
Mar 28, 2024K233657NAEOTOM Alpha
Siemens Medical Solutions USA, Inc.
JAK
Mar 26, 2024K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMA
Siemens Medical Solutions USA, Inc.
JAK
Mar 21, 2024K233753AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH, DE
JAK
Mar 13, 2024K232022CAS-One IR
Cascination AG, CH
JAK
Feb 22, 2024K233749Revolution Ascend Sliding
Ge Hangwei Medical Systems Co., Ltd., CN
JAK
Feb 8, 2024K233080HealthFLD
Nano-X AI , Ltd., IL
JAK
Jan 17, 2024K234030Clear Guide SCENERGY
Clear Guide Medical
JAK
Jan 8, 2024K232412LungQ v3.0.0
Thirona BV, NL
JAK
Jan 4, 2024K232136syngo.CT Applications
Siemens Medical Solutions USA, Inc.
JAK
Dec 6, 2023K233334Aquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems Corporation, JP
JAK
Dec 6, 2023K232206SOMATOM Pro.Pulse
Siemens Medical Solutions USA, Inc.
JAK
Nov 30, 2023K232155syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
JAK
Nov 29, 2023K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Nov 28, 2023K231631BriefCase-Quantification
Aidoc Medical , Ltd., IL
JAK
Nov 16, 2023K232392CT Lung Ventilation Analysis Software (CT:V)
4Dmedical Limited, AU
JAK
Oct 27, 2023K232045MeVis Liver Suite
MeVis Medical Solutions AG, DE
JAK
Oct 13, 2023K230370SpotLight/SpotLight Duo (with DLIR option)
Arineta , Ltd., IL
JAK
Oct 12, 2023K231574Scenaria View 4.2
FUJIFILM Healthcare Americas Corporation
JAK
Oct 11, 2023K230220NeuViz 128 Multi-Slice CT Scanner System
Neusoft Medical Systems Co., Ltd., CN
JAK
Oct 10, 2023K230130Micromate™ Navi+
Isys Medizintechnik GmbH, AT
JAK
Sep 19, 2023K231281Aquilion Serve (TSX-307A/1) V1.3
Canon Medical Systems Corporation, JP
JAK
Aug 1, 2023K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Jul 13, 2023K223424Spine Auto Views
GE Medical Systems SCS, FR
JAK
Jul 13, 2023K223261Open Rib
Canon Medical Informatics, Inc.
JAK
Jun 16, 2023K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, S
Siemens Medical Solutions USA, Inc.
JAK
Jun 13, 2023K230112CAC Software
Imbio, Inc.
JAK
Jun 1, 2023K223447OmniTom Elite
Neurologica Corporation, A Subsidiary of Samsung
JAK
May 3, 2023K223758Epione
Quantum Surgical Sas, FR
JAK
Apr 25, 2023K230223iCAC Device
Bunkerhill, Inc.
JAK
Apr 20, 2023K230807Deep Learning Image Reconstruction
Ge Healthcare Japan Corporation, JP
JAK
Apr 6, 2023K222360AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.
JAK
Mar 9, 2023K223514Spectral Bone Marrow
Ge Medical Systems, LLC
JAK
Mar 7, 2023K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems Corporation, JP
JAK
Mar 3, 2023K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation, JP
JAK
Feb 16, 2023K223028uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK

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