Search Results

The Trinias is an angiographic X-ray system which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures

Trinias is an interventional fluoroscopic x-ray system which uses digital x-ray receptor panels for image acquisition. The system has been modified to include new image enhancement software feature called "SCORE Opera." This new feature applies AI (deep learning technology) filter technology to enable efficient noise suppression and contrast enhancement, and to improve the visibility of devices that are generally difficult to achieve under low dose conditions, catheters for example.

The provided FDA 510(k) clearance letter and its associated summary for the "Trinias X-Ray System" (K252099) offer some details about the device's enhanced features and the studies conducted. However, it does not contain enough specific information to fully describe the acceptance criteria and the study that proves the device meets those criteria in the comprehensive manner requested.

Specifically, the document states:

• "The software was then subjected to non-clinical testing. Summary of non-clinical testing: We provided these detailed non-clinical test reports: The SCORE Opera Development process of leaning model AND a 2D Image Quality Evaluation Report."
• "Clinical testing: A clinical image quality study was conducted. The objective of the study was to evaluate the clinical image quality of X-ray images processed by the Trinias system's AI algorithm. The study aims to confirm that the AI-enhanced images (AI-ON) maintain diagnostic quality compared to standard image processing (AI-OFF). This assessment is submitted to support the determination of substantial equivalence. The results confirm that the AI-ON processing frequently provides improved visibility of interventional devices and vessels."

While these passages indicate that studies were performed, they lack crucial quantitative and qualitative details required to answer the specific questions below. The FDA 510(k) summary is generally an abbreviated public document; more detailed information would typically be found in the full 510(k) submission itself (which is not provided here).

Therefore, I will extract and present what can be deduced from the provided text, and explicitly state when information is missing.

Acceptance Criteria and Device Performance Study (K252099 - Trinias X-Ray System)

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific, quantifiable acceptance criteria (e.g., "AI-ON images must achieve a minimum diagnostic rate of X%," or "visibility scores must improve by Y points on a Z-point scale"). The reported performance is qualitative and comparative.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "A clinical image quality study was conducted" but provides no details on the number of images or cases included in this study.
• Data Provenance: Not specified. The country of origin of the data (e.g., images) used in the clinical study is not mentioned. It is unclear if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. No information is given on how discrepancies among experts (if multiple were used) were resolved or how the final "ground truth" for diagnostic quality and visibility was established.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: Not explicitly stated as an MRMC study, but a "clinical image quality study" comparing AI-ON and AI-OFF was conducted. This type of study often involves human readers, which aligns with the spirit of an MRMC study, even if not formally named such. The document states, "The study aims to confirm that the AI-enhanced images (AI-ON) maintain diagnostic quality compared to standard image processing (AI-OFF)."
• Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: Not quantified or reported. The document only qualitatively states that "the AI-ON processing frequently provides improved visibility of interventional devices and vessels." It does not provide any statistical effect size or direct measure of how much human readers improved their diagnostic performance or speed with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, implicitly. The AI algorithm's function is described as processing images ("AI (deep learning technology) filter technology to enable efficient noise suppression and contrast enhancement"). The "2D Image Quality Evaluation Report" mentioned under non-clinical testing likely includes standalone evaluations of the algorithm's output before human review, though specific metrics are not provided in this summary. The clinical study compared images from AI-ON vs. AI-OFF processing, implying these are the outputs of the standalone algorithm before human interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: Inferred to be expert consensus or expert interpretation. For a "clinical image quality study" aiming to assess "diagnostic quality" and "visibility of interventional devices and vessels," the ground truth would most typically be established by experienced clinicians (e.g., interventional radiologists/cardiologists) who review and rate the images. The document does not mention pathology, outcomes data, or other objective measures for ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document mentions "The SCORE Opera Development process of leaning model" (likely meaning "learning model"), indicating AI/deep learning training, but no details about the size or characteristics of the training data are provided.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established (Training Set): Not specified. For a deep learning model, the training set would require labeled data. The method for generating these labels (ground truth) is not described. This could involve manual annotation by experts, consensus, or other automated/semi-automated methods, but the document is silent on this point.

In summary, while the K252099 document confirms that a clinical image quality study and non-clinical evaluations were performed to support the new "SCORE Opera" AI feature, it lacks specific quantitative acceptance criteria, sample sizes for test and training data, details on expert qualifications, and the formal methodologies for ground truth establishment and adjudication. The reported performance is qualitative, stating "improved visibility" and maintenance of "diagnostic quality."

Ask a specific question about this device

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

aEvolve Imaging is an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).

The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging (FOV Extension), is an interventional X-ray system with a floor mounted C-arm as its main configuration. An optional ceiling mounted C-arm is available to provide a bi-plane configuration where required. Additional units include a patient table, X-ray high-voltage generator and a digital radiography system. The C-arms can be configured with designated X-ray detectors and supporting hardware (e.g. X-ray tube and diagnostic X-ray beam limiting device). With Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging (FOV Extension), the αEvolve Imaging feature now supports 12-inch, 10-inch, and 3-inch fields of view (FOV) for imaging in adult patients. The αEvolve imaging chain incorporates Artificial Intelligence Denoising (AID) for real-time fluoroscopic noise reduction, as well as Multi-Frequency Processing (MFP), a signal enhancement algorithm.

The provided 510(k) clearance letter describes performance testing for an interventional fluoroscopic X-ray system called "Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging (FOV Extension)". This device includes "Artificial Intelligence Denoising (AID)" and a "Multi Frequency Processing (MFP)" signal enhancement algorithm. The testing compares the subject device's αEvolve Imaging chain with AID to the predicate device's "super noise reduction filter (SNRF)".

Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined as the subject device performing "equivalent to or better than" the predicate, or "significantly better" (p < 0.05), or showing "no unexpected distortions" and "maintained or improved" performance.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for the test sets in terms of number of patients or images. The tests primarily utilized:

• Phantom data: Anthropomorphic chest phantoms and PMMA slab phantoms.
• Clinical datasets: Mentioned in image quality evaluations, but no further details provided regarding number or source.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The use of phantoms is a controlled laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The reported tests are primarily quantitative bench tests using phantoms or objective image quality metrics, not dependent on expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the tests involve quantitative metrics measured from phantoms or images, rather than human expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers is mentioned in the provided text. The testing focuses on objective image quality metrics using phantoms and clinical datasets.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the described performance testing is a standalone assessment of the αEvolve Imaging chain, including the Artificial Intelligence Denoising (AID) algorithm, without a human-in-the-loop component. The "reported device performance" directly reflects the algorithm's impact on image quality parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for most tests is derived from:

• Physical phantoms: Anthropomorphic chest phantoms and PMMA slab phantoms, which provide known geometries and material properties for objective measurement.
• Defined physical metrics: Metrics like image level, noise magnitude, SNR, NPS, kurtosis, MTF, NEQ, LCD, and CNR are calculated based on the image data and the known characteristics of the phantoms. There is no "ground truth" established by clinical experts or pathology in these technical bench tests.

8. The sample size for the training set

The document does not provide any information regarding the training set size for the Artificial Intelligence Denoising (AID) algorithm.

9. How the ground truth for the training set was established

The document does not provide any information on how the ground truth for the AID algorithm's training set was established.

Ask a specific question about this device

IntraSight Plus is a multi-function system intended to be used as an adjunct diagnostic tool for qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature in patients eligible for endovascular procedures.

The system, when configured with optional features, can also be used for:

• quantitative evaluation of coronary physiology using pressure-derived ratios,
• quantitative evaluation of coronary artery dimensions,
• enhanced visualization of stent or balloon placement in coronary arteries, and
• co-registration of an x-ray image with coronary intravascular ultrasound and/or coronary pressure-derived ratios

in patients eligible for percutaneous coronary intervention.

The IntraSight Plus IVUS function is indicated for use in patients undergoing conventional angiographic procedure to assess vascular morphology and to assess the need for additional treatment post percutaneous intervention. IVUS is obtained with a compatible ultrasound catheter and used as an adjunct to examine vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

The IntraSight Plus FFR and iFR functions are indicated for use in patients with signs of coronary artery disease undergoing coronary catheterization procedures to assess the hemodynamic significance of coronary lesions that may contribute to myocardial ischemia. FFR and iFR are obtained with a compatible pressure guide wire.

Philips IntraSight Plus is a multi-modality, application-based platform providing a range of imaging, physiology and co-registration tools. It can be integrated with a compatible interventional X-ray system.

Philips IntraSight Plus provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature in adult patients eligible for endovascular procedures. It is used to support conventional angiographic procedures, providing images of vessel lumen and wall structures.

N/A

Ask a specific question about this device

The Cara System is intended for preplanning and guidance of medical interventions in an area known to contain or be adjacent to the cardiac conduction system, such as percutaneous or surgical procedures, for example, transcatheter aortic valve replacement (TAVR), as well as medical procedures where the physician desires to deliver therapy to the patient's cardiac conduction system or to a targeted location within it (CSP).

The Cara System uses computed tomography angiography (CTA)-based and user manually marked landmarks to identify the cardiac conduction axis and generate a three-dimensional (3D) map of the individual patient's cardiac conduction system. The system also overlays the anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images.

The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters.

The CARA System is intended for use in adult patients (18 years of age and older).

The CARA System is a medical device comprising two integrated functions. The CARA System device components include the CARA Metis Simulator and the CARA Atlas Navigator. Both components provide diagnostic imaging software and hardware functions that identify the personalized anatomical location of the cardiac conduction system in relation to other heart anatomies based on a patient's computed tomographic angiography (CTA). The former is intended for preplanning (1) a medical intervention in an area known to contain or be adjacent to the cardiac conduction system or (2) a medical procedure(s) where the physician desires to deliver therapy to the patient's cardiac conduction system. The latter identifies the personalized anatomical location of the cardiac conduction system overlaid on real-time, intra-procedural, fluoroscopic imaging and provides guidance during interventional structural heart disease procedures in an area known to contain or be adjacent to the cardiac conduction system or where the physician desires to deliver therapy to the patient's cardiac conduction system.

The CARA Metis Simulator uses computed tomography angiography (CTA)-based landmarks to accurately identify the cardiac conduction axis and run a simulation generating the personalized three-dimensional (3D) map of the individual patient's cardiac conduction system.

This 3D map is then utilized by the clinical operator to plan any procedure to either target, as in direct pacing, or avoid as in structural heart disease interventions, the cardiac conduction system. As described below, this technology is based on methodical translational studies investigating the 3D location of the cardiac conduction system relative to cardiac structures visible by clinical imaging with initial assessment and validation in the clinical setting.

The CARA Atlas Navigator is designed to overlay the personalized anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images. This functionality assists clinicians during fluoroscopy-guided interventional heart procedures.

The Cara Atlas Navigator consists of both software and hardware components:

1. Fluoroscopy Splitter (F-Splitter) – This device splits the live fluoroscopy image for integration with the CARA System.

2. CARA Box – A standard workstation that receives live fluoroscopy images from the Fluoroscopy Splitter and enhances them by adding anatomical landmarks. The CARA Box acts as the system's central processing unit, handling data analysis and image processing. It is equipped with user interface devices, such as a mouse and keyboard.

3. CARA Monitor – Displays the enhanced fluoroscopy images, including the analysis performed by the CARA Box. This monitor is typically located in the control room. The same output is also projected onto the main display in the operating room.

The CARA System utilizes a specific on-premises workflow to ensure data integrity and clinical accuracy. Prior to physician use, a certified CARA Clinical Expert (CCE) must be physically present on-site. The CCE logs into the CARA Box workstation to prepare the CARA Metis pre-planning process. This includes initiating the automated segmentation, verifying the anatomical output, annotating landmarks, and saving the results to the local storage.

The physician subsequently logs into the same workstation using distinct credentials to load, review, and confirm the pre-planned case. This workflow ensures that all generated outputs are professionally prepared and verified before clinical review.

The CARA System utilizes AI/ML algorithms to provide OCR (Optical Character Recognition), automated segmentations and device tracking:

• OCR detection - is used to automatically extract metadata from the live feed of the fluoroscopy machine (e.g., c-arm position, focal distance, etc.).
• Segmentations - the system utilizes deep learning models to automatically generate anatomical segmentations of the heart chambers and aorta.
• Device Detection - using a segmentation model the system detects the distal tips of specific interventional devices (e.g., Pigtail catheters, CS catheters, pacing leads) within the fluoroscopic image to support real-time tracking and present overlay.

AI-based segmentations are provided to assist the workflow but may contain inaccuracies. The AI output should not be used as the sole basis for clinical decision-making. Clinical oversight is mandatory.

Here's a breakdown of the acceptance criteria and study details for the CARA System, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance Study for the CARA System

The CARA System's performance was evaluated through non-clinical, AI/ML validation, and retrospective clinical performance testing to demonstrate substantial equivalence to the predicate device, Cydar EV (K212442).

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for AI/ML Test Set

• OCR Test Set: 61 fluoroscopic images (retrospective, multi-site clinical datasets).
• Anatomical Segmentation (Cardiac Chambers) Test Set: 50 retrospective CT scans (retrospective, multi-site clinical datasets).
• Aortic Segmentation Test Set: 480 fluoroscopic images (retrospective, multi-site clinical datasets).
• Catheter & Lead Detection Test Set: 2,139 fluoroscopic images (retrospective, multi-site clinical datasets).

The specific country of origin for the retrospective, multi-site clinical datasets is not detailed in the provided information.

3. Number and Qualifications of Experts for Ground Truth

• Anatomical Segmentation (Cardiac Chambers) Ground Truth: Manual segmentation by trained technologists, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
• Aortic Segmentation Ground Truth: Manual contour annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
• Catheter & Lead Detection Ground Truth: Manual distal tip annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
• OCR Ground Truth: Manual verification of extracted parameters (no specific expert qualifications mentioned beyond "manual verification").

The number of experts (U.S. Board-Certified Interventional Cardiologists) used for adjudication is not specified (e.g., whether it was one individual or a panel).

4. Adjudication Method for the Test Set

The adjudication method clearly states "adjudicated by a U.S. Board-Certified Interventional Cardiologist." This implies a single expert review of the preliminary ground truth established by trained technologists/manual annotators. It does not indicate a 2+1 or 3+1 consensus method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned in the provided document. The study described focuses on the device's standalone performance and a retrospective clinical correlation, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the AI/ML algorithms. The "AI/ML Performance Summary" table directly details the performance of the OCR, anatomical segmentation, and catheter/lead detection algorithms on independent test datasets, measured against ground truth.

7. Type of Ground Truth Used

• AI/ML Algorithms: Expert consensus (adjudication by a U.S. Board-Certified Interventional Cardiologist) applied to initial manual annotations by trained technologists for anatomical segmentations and catheter/lead detection. Manual verification for OCR.
• Clinical Performance Data: Retrospective clinical outcomes data (Permanent Pacemaker Implantation rates, Left Ventricular Ejection Fraction improvement) associated with the CARA-visualized Conduction System Axis and Left Bundle Branch Pacing.

8. Sample Size for the Training Set

The document states, "Algorithms were trained using retrospective, multi-site clinical datasets," but does not specify the sample size used for the training set. It only mentions that "Training and test datasets were independent."

9. How the Ground Truth for the Training Set was Established

The document states, "Algorithms were trained using retrospective, multi-site clinical datasets." While it describes how ground truth was established for the validation/test set (manual segmentation by trained technologists with physician adjudication), it does not explicitly detail how the ground truth for the training set was established. It is implied that similar methods would have been used, but it's not directly stated.

Ask a specific question about this device

The ArmSure Fluoroscopic Positioning System is a software-enabled manual Assist Arm intended for use with fluoroscopic systems to assist in the visualization of the spatial relationship of attached compatible surgical instruments and interventional accessories on X-ray images, and to maintain the corresponding spatial position to hold the attached instrument or accessory.

The ArmSure system is intended to be used by trained healthcare professionals in a clinical environment, and is indicated for use during fluoroscopically-guided procedures involving the spine and long bones in patients whose anatomical size is suitable for the compatible instruments and the host fluoroscopic system.

The ArmSure Fluoroscopic Positioning System combines a software application with an Assist Arm to provide real-time visualization of surgical instrument locations within X-ray images. The visualization is derived from data transmitted by the Assist Arm to the ArmSure software, which performs calculations based on image coordination to superimpose the instrument's position onto the fluoroscopic X-ray images.

The Assist Arm is a manual, non-actuated device designed to be operated by the surgeon at the patient's side. The surgeon manually manipulates the Assist Arm in response to the interactive feedback displayed on the external screen, enabling precise instrument positioning through this real-time interface.

N/A

Ask a specific question about this device

The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:

• Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

• The Azurion series can be used in a hybrid Operating Room.
• The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

• Real-time image visualization of patient anatomy during procedures
• Imaging techniques and tools to assist interventional procedures
• Post processing functions after interventional procedures
• Storage of reference/control images for patient records
• Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
• Built in radiation safety controls.

The only changes to the subject device, Azurion R3.1 includes the design change to the mattress accessory for all the existing mattresses of the predicate device (Azurion R3.1, K251827, 24 October 2025) and introduction of new gray color mattress. The change includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table.

N/A

Ask a specific question about this device

The Orthoscan TAU MVP system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The scope used with Orthoscan TAU MVP system is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

The proposed Orthoscan TAU MVP (Multi Viewing Platform) Mini C-Arm system models 1000-0022, 1000-0023 retain identical function as the predicate Orthoscan TAU Mini C-Arm (K250587) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-Arm support attached to the image workstation.

The proposed Orthoscan TAU MVP Mini C-Arm system models 1000-0022, 1000-0023 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K250587). The proposed Orthoscan TAU MVP Mini C-Arm System will consist of the Orthoscan TAU Mini C-Arm X-ray System with additional arthroscopic imaging capability to further standardize the product platform by incorporating components currently available in predicate devices into the Orthoscan TAU MVP system.

The proposed new Orthoscan TAU MVP system is a collaborative effort to display the fluoroscopic and arthroscopic image concurrently.

The proposed modifications to the predicate encompass the incorporation of hardware and software from MIDASVu arthroscopic imaging system reusable tablet (K243020) utilizing a modified mechanical design to incorporate a video processing unit imaging control board, umbilical cord and arthroscopic imaging system comprised of sterile, single-use scopes (K243020). The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and the TAU MVP Mini C-Arm system work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.

N/A

Ask a specific question about this device

The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for:

• Handheld orthopedic radiographic procedures of the extremities.
• Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only.
• Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees.

The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure.

The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).

The device is NOT intended to be used in environments with the following characteristics:

• Aseptic or sterile fields, such as in surgery
• Home or residential settings or other settings where qualified operators are not present
• Vehicular and moving environments
• Environments under direct sunlight
• Oxygen-rich environments, such as near an operating oxygenation concentrator

The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of the shoulders to fingertips and knees to toes. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.

The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs.

The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.

N/A

Ask a specific question about this device

The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.

SKAN C Pulsar is not recommended for Cardiac Applications.

SKAN C Pulsar surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

The SKAN C Pulsar, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.

SKAN C Pulsar is a Mobile fluoroscopy C-Arm consisting of two main units:
a) C-arm main unit
b) A Workstation or Monitor Cart

The C-arm unit is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and a Console. C-arm has provision for mechanical movement of C-arm for Orbital and Yoke Rotation along with vertical and wig-wag movements.

Workstation or Monitor cart is composed of a monitor, keyboard and computing system.

The operating principle of the device is to expose X-ray, which are passed through the human body and falls on the sensor. The intensity of X-ray can be adjusted to required level. Detector follows two step conversion. It converts X-ray into light and Light is converted into electrical signal. Electrical signal is than digitized and stored. This stored information is processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device.

N/A

Ask a specific question about this device

The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

GE HealthCare interventional x-ray systems are designed to perform monoplane fluoroscopic X-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures. Additionally, with an OR table, these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.

Allia™ Moveo is a GE HealthCare interventional X-Ray system product model. It consists of a C-arm positioner, an X-ray table, an X-ray tube assembly, an X-ray power unit with its exposure control unit, an X-ray imaging chain (including a digital detector and an image processing unit).

Allia™ Moveo is a monoplane system (C-arm with mobile AGV gantry), with a square 41cm digital detector and the InnovaIQ table (with an option to make it an OR table).

Allia™ Moveo is an image acquisition system requiring connection to the GE HealthCare Advantage Workstation (AW) for 3D reconstruction. When a 3D acquisition is performed on the Allia™ Moveo system, the acquired 2D images are transferred to the Advantage Workstation (AW) to be processed by 3DXR (reference device K243446) for 3D reconstruction.

The purpose of this Premarket Notification is the introduction of a new C-arm with a modified detector mount.

N/A

Ask a specific question about this device