Search Results
Found 536 results
510(k) Data Aggregation
K Number
K251322Device Name
Venue; Venue Go; Venue Fit; Venue Sprint
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2025-07-25
(87 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K251342Device Name
EchoPAC Software Only / EchoPAC Plug-in
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Date Cleared
2025-07-16
(77 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K251169Device Name
Vivid Pioneer
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Date Cleared
2025-07-10
(86 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K242562Device Name
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Manufacturer
GE Medical Systems Information Technologies, Inc.
Date Cleared
2025-07-09
(315 days)
Product Code
MHX, BZQ, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Information Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K243672Device Name
CardIQ Suite
Manufacturer
GE Medical Systems SCS
Date Cleared
2025-06-18
(203 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems SCS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. The clinician can use the information provided by calcium scoring to monitor the progression/regression of calcium in coronary arteries overtime, and this information may aid the clinician in their determination of the prognosis of cardiac disease. CardIQ Suite also provides an estimate of the volume of heart fat for informational use.
Device Description
CardIQ Suite is a non-invasive software application designed to work with DICOM CT data acquisitions of the heart. It is a collection of tools that provide capabilities for generating measurements both automatically and manually, displaying images and associated measurements in an easy-to-read format and tools for exporting images and measurements in a variety of formats.
CardIQ Suite provides an integrated workflow to seamlessly review calcium scoring and coronary CT angiography (CCTA) data. Calcium Scoring has a fully automatic capability which will detect calcifications within the coronary arteries, label the coronary arteries according to regional territories and generate a total and per territory calcium score based on the AJ 130 and Volume scoring methods. Interactive tools allow editing of both the auto scored coronary lesions and other calcified lesions such as aortic valve, mitral valve as well as other general cardiac structures. Calcium scoring results can be compared with two percentile guide databases to better understand a patient's percentage of risk based on age, gender, and ethnicity. Additionally, for these non-contrasted exams, the heart fat estimation automatically estimates values within the heart that constitute adipose tissue, typically between –200 and –30 Hounsfield Units.
Calcium Scoring results can be exported as DICOM SR, batch axial SCPT, or a PDF report to assist with integration into structured reporting templates. Images can be saved and exported for sharing with referring physicians, incorporating into reports and archiving as part of the CT examination.
The Multi-Planar Reformat (MPR) Cardiac Review and Coronary Review steps provide an interactive toolset for review of cardiac exams. Coronary CTA datasets can be reviewed utilizing the double oblique angles to visually track the path of the coronary arteries as well as to view the common cardiac chamber orientations. Cine capability for multi-phase data may be useful for visualization of cardiac structures in motion such as chambers, valves and arteries, automatic tracking and labeling will allow a comprehensive analysis of the coronaries. Vessel lumen diameter is calculated, and the minimum lumen diameter computed is shown in color along the lumen profile.
Distance measurement and ROI tools are available for quantitative evaluation of the anatomy. Vascular findings of interest can be identified and annotated by the user, and measurements can be calculated for centerline distances, cross-sectional diameter and area, and lumen minimum diameter.
Ask a Question
K Number
K251153Device Name
Aurora
Manufacturer
GE Medical Systems Israel
Date Cleared
2025-06-12
(59 days)
Product Code
KPS, JAK
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Israel
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.
Device Description
GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.
Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system.
Ask a Question
K Number
K243667Device Name
Sonic DL
Manufacturer
GE Medical Systems, LLC
Date Cleared
2025-06-05
(190 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sonic DL is a Deep Learning based reconstruction technique that is available for use on GE HealthCare 1.5T, 3.0T, and 7.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for imaging patients of all ages. Sonic DL is not limited by anatomy and can be used for 2D cardiac cine imaging and 3D Cartesian imaging using fast spin echo and gradient echo sequences. Depending on the region of interest, contrast agents may be used.
Device Description
Sonic DL is a software feature intended for use with GE HealthCare MR systems. It includes a deep learning based reconstruction algorithm that enables highly accelerated acquisitions by reconstructing MR images from highly under-sampled data. Sonic DL is an optional feature that is integrated into the MR system software and activated through purchasable software option keys.
Ask a Question
K Number
K250543Device Name
Voluson Performance 16; Voluson Performance 18
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics
Date Cleared
2025-05-29
(94 days)
Product Code
IYN, ITX, IYO, QIH
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Voluson™ Performance 16 / Voluson™ Performance 18 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson™ Performance 16 / Voluson™ Performance 18 clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ Performance 16 / Voluson™ Performance 18 system are intended to be used in a hospital or medical clinic.
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
Ask a Question
K Number
K250087Device Name
Vscan Air
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Date Cleared
2025-05-01
(107 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Pulsed wave Doppler mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional), pediatrics, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatric, 40 kg and above), abdominal, fetal/obstetrics, gynecological, urology, thoracic/ lung, pediatrics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
Device Description
Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
Ask a Question
K Number
K243651Device Name
VersaViewer
Manufacturer
GE Medical Systems SCS
Date Cleared
2025-04-21
(146 days)
Product Code
LLZ, QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems SCS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VersaViewer is a medical diagnosis software supporting 2D, 3D and 4D medical images series for their processing and analysis through customizable layouts allowing multimodality review. It streamlines standard and advanced medical imaging analysis by providing a suite of measurements capabilities. It is designed for use by trained healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
VersaViewer is not intended for the displaying of digital mammography images for diagnosis.
Device Description
VersaViewer is a software application for processing and analysis of 2D, 3D and 4D medical imaging data. The application provides adaptive layout to display selected series and, common radiology toolset to perform measurements. It aims to enable the review of medical imaging acquisitions for which a dedicated advanced visualization application is not required.
VersaViewer has the following functionalities:
- Reconstruct and display 2D, 3D and 4D medical images from multiple modalities.
- Display relevant series in an adaptive layout based on user selection.
- Access and dynamically load series of interest through embedded Series Selector.
- Allow to select different image rendering modes such as Volume Rendering, MIP (maximum intensity projection) /MinIP (minimum intensity projection) / Average, MPR (multiplanar reformation) and Oblique.
- Basic image review tools including paging, WW/WL adjustment and zoom. 3D volumes can be visualized in adjustable multi-oblique planes.
- Set of annotation, measurement, and segmentation tools.
- Dedicated panel collects findings as they are deposited on the images and enables user to manage them.
- Images and findings export options.
VersaViewer also includes One View as an optional feature.
One View provides reformatted views to assist radiologists in interpreting various types of spectral exams by projecting GSI (Gemstone Spectral Imaging) material decomposition images over monochromatic and color overlay.
Ask a Question
Page 1 of 54