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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.

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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.

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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.

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The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.

The OEC One CFD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.

The subject device is labelled as OEC One CFD.

Here's a summary of the acceptance criteria and the study details for the OEC One CFD device, specifically focusing on the new "Deep learning-based Trajectory Pointer software" feature, as that's where the most detailed study information is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Trajectory Pointer)

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

• Total image dataset: 3078 images
• Test set size: 307 images (approx. 10% of the total dataset)
• Data Provenance (Ethnicity/Country):
  • US: 51.1%
  • China: 35.8%
  • Phantom: 9.8%
  • EU/Australia: 3.3%
• Data type: The document states that sample clinical images were evaluated to demonstrate substantial equivalence, and "all images were collected from GE OEC Mobile C-arm devices," suggesting retrospective collection of clinical images, alongside phantom data. It also notes that the test data covers the "entire range of values for all confounders," implying it's representative of real-world scenarios.

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

• Number of Experts: 3
• Qualifications: U.S. board-certified radiologists. (No specific years of experience are listed).

4. Adjudication Method for the Test Set

• The document states: "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."
• This implies a consensus or verification process by multiple experts to validate the initial manual annotations, but a specific method like "2+1" or "3+1" is not explicitly mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The performance metrics reported are for the algorithm's standalone performance.

6. If a Standalone (Algorithm Only) Performance Study was Done

• Yes, a standalone performance study was done for the Trajectory Pointer feature. The reported success rates of 98.8% for LIH images and 97.1% for Fluoroscopy images (both exceeding the 95% MAAP) are measures of the algorithm's performance.

7. The Type of Ground Truth Used

• For the Trajectory Pointer feature, the ground truth was established by expert consensus/manual annotation. Specifically, "the contours of K-wires were manually outlined by trained annotators," and "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."

8. The Sample Size for the Training Set

• Training set size: 2771 images (3078 total images - 307 test images = 2771 images). The document states: "Total dataset included 3078 images, 307 were used for test dataset and the rest for training/tuning."

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

• While not explicitly detailed for the training set, it is highly probable that the ground truth for the training data was established in a similar manner to the test set: through manual outlining of K-wire contours by trained annotators. The document mentions "comparing ground truth annotations" during deduplication, implying annotations were available for the training data.

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The Geelin500A/Geelin500M is a mobile digital X-ray C-Arm diagnostic system, which Is Intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The Geelin500A/Geelin500M permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

The Dual-Mode Mobile C-Arm is divided into two models: Geelin500A and Geelin500M.

Both models comprise:

• X-ray generator (consisting of monoblock head, inverter, and collimator)
• X-ray imaging device (including digital image detector, image display, Touch Screen, and industrial computer)
• C-Arm retractable rack
• Accessories (consist of battery, movement control handle, exposure footswitch, and laser)
• Software: Digital image processing software CMXPS-500, software release version V1.0.0.

Differences between Geelin500A and Geelin500M:

• Base plate: The chassis of the Geelin500M is equipped with swivel casters and requires manual pushing to move the equipment. The chassis of the Geelin500A is equipped with an electric motor, allowing movement of the equipment using the movement control handle.
• SID (Source-to-Image Distance): Geelin500A has a variable SID (range: 0-250mm). Geelin500M has an invariable SID.
• Distance from the X-ray tube focus to the image intensifier (lateral view): The C-arm of Geelin500A is equipped with a retractable digital image detector mechanism, allowing for a variable SID from the tube focus to the detector plane (AP/LAT 1050 mm, variable (range 0-250mm)). For Geelin500M, SID is AP 1050mm /LAT 1200mm, invariable.

The Dual-Mode Mobile C-Arm is an X-ray device with dual-plane (A-vertical direction and B-horizontal direction) imaging function. Its main components are configured as follows:

1. Two E-40R HF/IMD XR05 combined X-ray generators (40kHz, using rotating anode X-ray tubes, suitable for fluoroscopy and digital radiography) produced by IMD CHINA CO.,LTD. Small focus: 0.3mm, nominal anode input power: 0.6kW; Large focus: 0.6mm, nominal anode input power: 5kW.
2. Two E-9040-5HF inverters produced by IMD CHINA CO.,LTD.
3. Two PaxScan2121DXV flat panel detectors produced by Varian Medical Systems.
4. The C-arm installs the two sets of X-ray systems on a 3/4 circular arc arm on the mechanical structure, and the ray directions of the two sets of systems are perpendicular to each other, showing an orthogonal relationship.
5. The ray control system of C-arm is composed of single chip microcomputer and configuration touch screen. The signals from the combined X-ray generator and inverter are converted into signals that can be received and processed by the single chip microcomputer through the exposure control board. At the same time, the AD\DA module of the microcontroller provides filament preheating signals and kV setting signals for the ray generator and the inverter, and receives feedback signals from the inverter and the filament board.
6. The exposure program is controlled by the relevant program in the microcontroller. After stepping on the foot brake exposure pedal, the foot brake signal will enter the single-chip microcomputer program, and the single-chip microcomputer will determine whether the ray system (flat panel detector state, inverter state and filament state, etc.) is abnormal (error or warning) in real time. Under the normal condition of the system and the inverter without abnormality, the single-chip microcomputer will continue to delay 0.8 seconds to give the exposure command signal to the inverter. After receiving the exposure command signal, the inverter immediately executes the exposure command and excites the X-ray generator to release X-rays. At the same time, the inverter will monitor the kV feedback signal in real time. When the feedback signal is abnormal or the inverter is abnormal, the inverter will immediately transmit the signal to the single chip microcomputer, and the relevant error information will be realized on the touch screen, and the exposure command will be immediately forced to end. The filament board will also monitor the filament status in real time. When the filament board is abnormal or the filament current preheating is abnormal, the filament board will immediately transmit the signal to the microcontroller, and the relevant error information will be realized on the touch screen, and the exposure will be forced to end immediately.
7. The image generated by exposure is transmitted to the image processing workstation through the flat panel detector, and the workstation displays the image on the display screen after proper image processing.

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The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care, and in Veterinary Medicine.

The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

The Cios Select (VA21F) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21F) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K223410 on December 7, 2022.

The Cios Select consists of two major units:

The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station.

The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls.

The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (USB).

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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.

Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.

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

This array of functions offers the physician the imaging information and tools needed to perform and document minimally invasive interventional procedures.

The Azurion R3.1 is available in identical models and configurations as the predicate device Azurion R2.1. Configurations are composed of detector type, monoplane (single C-arm) or biplane (dual arm), floor or ceiling mounted geometry, standard or OR table type and available image processing.

Identical to the predicate device, the FlexArm option is available for the 7M20 configuration in Azurion R3.1 to increase flexibility in stand movement.

Additionally, identical to the predicate device, Azurion R3.1 can be used in a hybrid operating room when supplied with a compatible operating room table.

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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.

αEvolve 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, 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). The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging includes αEvolve Imaging, 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).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided FDA 510(k) summary:

Overview of the Device and its New Feature:

The device is the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging. It's an interventional X-ray system. The new feature, αEvolve Imaging, includes Artificial Intelligence Denoising (AID) to reduce noise in real-time fluoroscopic images and a signal enhancement algorithm, Multi Frequency Processing (MFP). The primary claim appears to be improved image quality (noise reduction, sharpness, contrast, etc.) compared to the previous version's (V9.5) "super noise reduction filter (SNRF)."

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes various performance evaluations and their successful outcomes. For the clinical study, the success criteria are clearly defined.

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

The 510(k) summary provides the following information about the clinical test set:

• Clinical Dataset Source: Patient image sequences were acquired from three hospitals:
  • Memorial Hermann Hospital (Houston, Texas, USA)
  • Waikato Hospital (Hamilton, New Zealand)
  • Saiseikai Kumamoto Hospital (Kumamoto, Japan)
• Data Provenance: The study used retrospective "patient image sequences" for side-by-side comparison. The summary does not specify if the acquisition itself was prospective or retrospective, but the evaluation of pre-existing sequences makes it a retrospective study for the purpose of algorithm evaluation.
• Sample Size: The exact number of patient image sequences or cases used in the clinical test set is not specified in the provided document. It only mentions that the sequences were split into four BMI subgroups.

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

• Number of Experts: The document states the clinical comparison was "reviewed by United States board-certified interventional cardiologists." The exact number of cardiologists is not specified.
• Qualifications: "United States board-certified interventional cardiologists." No mention of years of experience or other specific qualifications is provided.

4. Adjudication Method for the Test Set

The document describes a "side-by-side comparison" reviewed by experts in the clinical performance testing section. For the overall preference and individual image quality metrics, statistical tests (Wilcoxon signed rank test and Binomial test) were used. This implies that the experts rated or expressed preference for both AID and SNRF images, and these individual ratings/preferences were then aggregated and analyzed.

The exact adjudication method (e.g., 2+1, 3+1 consensus) for establishing a ground truth or a final decision on image quality aspects is not explicitly stated. It seems each expert provided their assessment, and these assessments were then statistically analyzed for superiority rather than reaching a consensus for each image pair.

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

• MRMC Study: Yes, a type of MRMC comparative study was conducted. The clinical performance testing involved multiple readers (US board-certified interventional cardiologists) evaluating multiple cases (patient image sequences).

• Effect Size of Human Readers' Improvement with AI Assistance: The study directly compared AID-processed images to SNRF-processed images in a side-by-side fashion. It doesn't measure how much humans improve with AI assistance in a diagnostic task (e.g., how much their accuracy or confidence improves when using AI vs. not using AI). Instead, it measures the perceived improvement in image quality of the AI-processed images when evaluated by human readers.

  • The study determined: "the mean score of the AID imaging chain images was significantly higher than that of the SNRF imaging chain with regard to sharpness, contrast, confidence, noise, and the absence of image artifacts."
  • And for overall preference, "the Binomial test found that the image sequences denoised by AID were chosen significantly more than 50% of the time."

  This indicates a statistically significant preference for and higher perceived image quality in AID-processed images by readers. However, it does not quantify diagnostic performance improvement with AI assistance, as it wasn't a study of diagnostic accuracy but rather image quality assessment. The "confidence" metric might hint at improved reader confidence using AID images, but it's not a direct measure of diagnostic effectiveness.

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

Yes, extensive standalone performance testing of the AID algorithm was conducted through "Performance Testing – Bench" and "Image Quality Evaluations." This involved objective metrics and phantom studies without human subjective assessment.

Examples include:

• Change in Image Level, Noise and Structure
• Signal-to-Variance Ratio (SVR) and Signal-to-Noise Ratio (SNR)
• Modulation Transfer Function (MTF)
• Robustness to Detector Defects (visual comparison, but the algorithm's output is purely standalone)
• Normalizes Noise Power Spectrum (NNPS)
• Image Lag Measurement
• Contrast-to-Noise Ratio of a Low Contrast Object
• Contrast-to-Noise Ratio of a High Contrast Object

7. The Type of Ground Truth Used

• For Bench Testing: The ground truth for bench tests was primarily established through physical phantoms and objective image quality metrics. For example, the anthropomorphic chest phantom, low-contrast phantom, and flat field fluoroscopic images provided known characteristics against which AID and SNRF performance were measured using statistical tests.
• For Clinical Study: The ground truth for the clinical reader study was established by expert opinion/subjective evaluation (preference and scores for sharpness, contrast, noise, confidence, absence of artifacts) from "United States board-certified interventional cardiologists." There is no mention of a more objective ground truth like pathology or outcomes data for the clinical image evaluation.

8. The Sample Size for the Training Set

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

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

The document does not provide any information about how the ground truth for the training set was established. It describes the AID as "Artificial Intelligence Denoising (AID) designed to reduce noise," implying a machine learning approach, but details on its training are missing from this summary.

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Self-Propelled CT Scan Base Kit, CGBA-035A:
The movable gantry base unit allows the Aquilion ONE (TSX-308A) system to be installed in the same procedure room as the INFX-8000C system, enabling coordinated clinical use within a shared workspace. This configuration provides longitudinal positioning along the z-axis for image acquisition.

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP:
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. The Calculated Dose Area Product (DAP) feature provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

The Alphenix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-308A. This combination enables patient access and efficient workflow for interventional procedures. Self-Propelled CT Scan Base Kit, CGBA-035A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the fixed catheterization table utilized by the interventional x-ray system, INFX-8000C. The Self-Propelled CT Scan Base Kit, CGBA-035A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.

The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP, is an interventional x-ray system with a ceiling suspended C-arm as its main configuration. 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). The INFX-8000C system incorporates a Calculated Dose Area Product (DAP) feature, which provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

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Intended for use by a qualified/trained physician or technician for obtaining fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Rx only.

The Insight Enhanced™ DRF is an upgrade package that is designed to be installed on existing fluoroscopic systems, referred to as host system, to convert the imaging chain from analog to digital. It is comprised of the Insight Enhanced™ DRF Digital Imaging chain and associated interfacing hardware. The Insight Enhanced™ DRF system includes medical grade monitors, computer, and flat panel detector. Interface boards, cabling, and signal converters are included for interfacing with the host system. The x-ray generator and x-ray tube are not modified in any way. A flat panel detector replaces the image intensifier and camera on the base system. All of the fundamental features and principles of operation Insight Enhanced™ DRF are identical to the predicate device, Insight Enhanced™ (K200369). Both systems are upgrade packages that replace an analog imaging chain with a new digital one. The main components of the product, the PC, software, and detector for the predicate device and for the subject device are identical. Mounting hardware and interfacing components differ to add compatibility to GE OEC 9800/9900 C-arms. Insight Enhanced™ DRF is designed as an upgrade package for General Electric Legacy and P500 fluoroscopy rooms. This submission adds compatibility to a device, the OEC 9800/9900.

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