System, X-ray, Tomography, Computed

Product Code: JAK

Radiology Medical Diagnostic X-Ray Equipment

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1750


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as JAK

5360System, X-ray, Tomography, ComputedComputed Tomography X-ray System.

Total Product Life Cycle (TPLC) Devices

5360System, X-ray, Tomography, ComputedComputed Tomography X-ray System.

FDA Consensus Standards

System, X-Ray, Tomography, Computed [33222]21 CFR §892.1750 🔎
System, X-Ray, Tomography, Computed [34029]21 CFR §892.1750 🔎
System, X-Ray, Tomography, Computed [32779]21 CFR §892.1750 🔎
System, X-Ray, Tomography, Computed [29018]21 CFR §892.1750 🔎
System, X-Ray, Tomography, Computed [32091]21 CFR §892.1750 🔎
System, X-Ray, Tomography, Computed [37176]21 CFR §892.1750 🔎

Pre-market Notifications for JAK

K212494Lung Image AnalysisPulmonx Corporation
K212067Deep Learning Image ReconstructionGE Healthcare Japan Corporation
K211828Aquilion Exceed LBCanon Medical Systems Corporation
K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.
K211373SOMATOM Go.Platform Scanners - SOMATOM Go.Now, Go.Up, Go.All, Go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite And SOMATOM X.ceed, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.
K210085HealthCCSngZebra Medical Vision Ltd.
K203699Syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.
K203617MaxFOV 2GE Medical Systems, LLC.
K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.
K203448UCT ATLAS With UWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.
K203411Syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.
K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.
K203225Aquilion ONE (TSX-306A/3) V10.4 With Spectral Imaging SystemCanon Medical Systems Corporation
K203169Revolution AscendGE Healthcare Japan Corporation
K203042Aquilion Exceed LB (TSX-202A/3) V10.6 With AiCE-ICanon Medical Systems Corporation

Global Unique Device Identification Database

00815686021146System, X-Ray, Tomography, Computed
00815686021139System, X-Ray, Tomography, Computed
00815686021122System, X-Ray, Tomography, Computed
00815686021108System, X-Ray, Tomography, Computed
00815686021092System, X-Ray, Tomography, Computed
00815686021085System, X-Ray, Tomography, Computed
00815686021078System, X-Ray, Tomography, Computed
00815686021061System, X-Ray, Tomography, Computed
00815686020927System, X-Ray, Tomography, Computed
00815686020804System, X-Ray, Tomography, Computed
00815686020736System, X-Ray, Tomography, Computed
00815686020729System, X-Ray, Tomography, Computed
00815686020712System, X-Ray, Tomography, Computed
00815686020705System, X-Ray, Tomography, Computed
00815686020699System, X-Ray, Tomography, Computed

Maude Adverse Events

BRILLIANCE AIR 40/64/UCTPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.2020-03-27
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-03-25
SOMATOM FORCESIEMENS HEALTHCARE GMBH2020-03-23
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-03-20
BRILLIANCEPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.2020-03-10
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-03-10
EDGECOVIDIEN LP - SUPERDIMENSION INC2020-03-08
SOMATOM DRIVESIEMENS HEALTHCARE GMBH2020-03-04
SOMATOM DRIVESIEMENS HEALTHCARE GMBH2020-03-04
OMNITOMNEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS)2020-02-28
SOMATOM DRIVESIEMENS HEALTHCARE GMBH2020-02-27
SOMATOM DEFINITION ASSIEMENS HEALTHCARE GMBH2020-02-27
OMNITOMNEUROLOGICA CORPORATION2020-02-26
CERETOMNEUROLOGICA CORPORATION2020-02-21
ILLUMISITECOVIDIEN LP - SUPERDIMENSION INC2020-02-21
OMNITOMNEUROLOGICA CORP.2020-02-06
SOMATOM DEFINITION FLASHSIEMENS HEALTHCARE GMBH2020-02-05
SOMATOM DEFINITION FLASHSIEMENS HEALTHCARE GMBH2020-02-03
EDGE CATHETER SYSTEMCOVIDIEN LP - SUPERDIMENSION INC2020-01-31
ILLUMISITECOVIDIEN LP - SUPERDIMENSION INC2020-01-30
SOMATOM DEFINITION EDGESIEMENS HEALTHCARE GMBH2020-01-29
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-01-28
SOMATOM PERSPECTIVESIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.2020-01-22
SOMATOM DEFINITION ASSIEMENS HEALTHCARE GMBH2020-01-22
BRILLIANCE AIR 40/64/UCTPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.2020-01-20
2020-01-16
BRILLIANCE AIR 40/64/UCTPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.2020-01-16
SOMATOM FORCESIEMENS HEALTHCARE GMBH2020-01-09
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-01-09
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-01-08
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2020-01-02
SOMATOM DRIVESIEMENS HEALTHCARE GMBH2019-12-04
EDGECOVIDIEN LP - SUPERDIMENSION INC2019-11-26
SOMATOM DEFINITION FLASHSIEMENS HEALTHCARE GMBH2019-11-26
SOMATOM DEFINITION ASSIEMENS AG/SIEMENS HEALTHCARE GMBH2019-11-26
EDGECOVIDIEN LP - SUPERDIMENSION INC2019-11-18
SOMATOM DEFINITION FLASHSIEMENS HEALTHCARE GMBH2019-11-14
SOMATOM DRIVESIEMENS HEALTHCARE GMBH2019-11-14
EDGECOVIDIEN LP - SUPERDIMENSION INC2019-11-01
CANONCANON MEDICAL SYSTEMS CORPORATION2019-10-31
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2019-10-28
SOMATOM PERSPECTIVESIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.2019-10-28
SOMATOM DEFINITION ASSIEMENS HEALTHCARE GMBH2019-10-28
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2019-10-25
OPTIMA NM/CT 640GE MEDICAL SYSTEMS ISRAEL2019-10-24
SPIN THORACIC NAVIGATION SYSTEM/ALWAYS-ON TIP TRACKED FORCEPS SERRATED CUPVERAN MEDICAL TECHNOLOGIES, INC.2019-10-21
SOMATOM DEFINITION ASSIEMENS HEALTHCARE GMBH2019-10-18
SUPERDIMENSIONCOVIDIEN LP - SUPERDIMENSION INC2019-10-15
SUPERDIMENSION INREACH SYSTEMCOVIDIEN LP - SUPERDIMENSION INC2019-10-11
SOMATOM SENSATION 64/SENSATION CARDIACSIEMENS HEALTHCARE GMBH2019-10-11

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