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510(k) Data Aggregation
(174 days)
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(156 days)
Archy Dental Imaging is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in the form of digital images. The system uses a Web-based interface and includes acquisition, editing, and storage of digital images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast adjusted, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
Archy Dental Imaging is a cloud-based dental imaging software that allows access to diagnostic radiological and photo images on any PC with an active internet connection via modern web browser. Archy Dental Imaging contains all key features present in traditional client-server based dental imaging software.
Archy Dental Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. Images stored using Archy Dental Imaging are saved using lossless compression and can be exported as DICOM or PNG files. The original images are treated as immutable by the rest of the system.
Archy Dental Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors, intraoral cameras, and scanners. Archy Dental Imaging is imaging software designed for use in dentistry. The main Archy Dental Imaging software functionality includes image acquisition, organization, and annotation. Archy Dental Imaging is used by dental professionals for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Dentists and other qualified individuals can display and review images, apply annotations, and manipulate images. Archy Dental Imaging is the imaging component of Archy, a full-featured dental practice management system that handles scheduling, charting, and other practice business concerns. The software operates within a web browser upon standard consumer PC hardware and displays images on the PC's connected display/monitor. The subject device is the Archy Dental Imaging software; the computer or the monitor are not part of the submission.
Archy Dental Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interpreting images and information being displayed and printed.
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(23 days)
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.
syngo.MR Applications is a software only Medical Device consisting post-processing applications/workflows used for viewing and evaluating the designated images provided by a MR diagnostic device. The post-processing applications/workflows are integrated with the hosting application syngo.via, that enables structured evaluation of the corresponding images
The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) indicate that no clinical studies or bench testing were performed to establish new performance criteria or demonstrate meeting previously established acceptance criteria. The submission focuses on software changes and enhancements from a predicate device (syngo.MR Applications VB40).
Therefore, based solely on the provided document, I cannot create the requested tables and information because the document explicitly states:
- "No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device."
- "No bench testing was required to be carried out for the product."
The document details the following regarding performance and acceptance:
- Non-clinical Performance Testing: "Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
- Software Verification and Validation: "The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo.MR Applications during product development... The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
- Conclusion: "The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use."
This implies that the acceptance criteria are related to the functional specifications and performance of the software, as demonstrated by internal verification and validation activities, rather than a clinical performance study with specific quantitative metrics. The new component, "MR Prostate AI," is noted to be integrated without modification and had its own prior 510(k) clearance (K241770), suggesting its performance was established in that separate submission.
Without access to the actual verification and validation reports mentioned in the document, it's impossible to list precise acceptance criteria or detailed study results. The provided text only states that "all the software specifications have met the acceptance criteria."
Therefore, I can only provide an explanation of why the requested details cannot be extracted from this document:
Explanation Regarding Acceptance Criteria and Study Data:
The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) explicitly state that no clinical studies or bench testing were performed for this submission. The device (syngo.MR Applications VB80) is presented as a new version of a predicate device (syngo.MR Applications VB40) with added features and enhancements, notably the integration of an existing AI algorithm, "Prostate MR AI VA10A (K241770)," which was cleared under a separate 510(k).
The basis for clearance is "non-clinical performance data" and "software validation data" demonstrating that the subject device performs comparably to and is as safe and effective as the predicate device. The document mentions that "all the software specifications have met the acceptance criteria" as part of the verification and validation (V&V) activities. However, the specific quantitative acceptance criteria, detailed performance metrics, sample sizes, ground truth establishment, or expert involvement for these V&V activities are not included in this public summary.
Therefore, the requested information cannot be precisely extracted from the provided text.
Summary of Information Available (and Not Available) from the Document:
| Information Requested | Status (Based on provided document) |
|---|---|
| 1. Table of acceptance criteria and reported performance | Not provided in the document. The document states: "The testing results support that all the software specifications have met the acceptance criteria." However, it does not specify what those acceptance criteria are or report detailed performance metrics against them. These would typically be found in the detailed V&V reports, which are not part of this summary. |
| 2. Sample size and data provenance for test set | Not provided. The document indicates "non-clinical tests were conducted as part of verification and validation activities." The sample sizes for these internal tests, the nature of the data, and its provenance (e.g., country, retrospective/prospective) are not detailed. It is implied that the data is not patient-specific clinical test data. |
| 3. Number of experts and qualifications for ground truth | Not applicable/Not provided. Since no clinical studies or specific performance evaluations against an external ground truth are described in this document, there's no mention of experts establishing ground truth for a test set. The validation appears to be against software specifications. If the "MR Prostate AI" component had such a study, those details would be in its individual 510(k) (K241770), not this submission. |
| 4. Adjudication method for test set | Not applicable/Not provided. As with the ground truth establishment, no adjudication method is mentioned because no external test set requiring such expert consensus is described within this 510(k) summary. |
| 5. MRMC comparative effectiveness study and effect size | Not performed for this submission. The document explicitly states "No clinical studies were carried out for the product." Therefore, no MRMC study or AI-assisted improvement effect size is reported here. |
| 6. Standalone (algorithm only) performance study | Partially addressed for a component. While this submission doesn't detail such a study, it notes that the "MR Prostate AI" algorithm is integrated without modification and "is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission." This implies that a standalone performance study was done for the Prostate MR AI algorithm under its own 510(k) (K241770), but those details are not within this document. For the overall syngo.MR Applications (VB80) product, no standalone study is described. |
| 7. Type of ground truth used | Not provided for the overall device's V&V. The V&V activities are stated to have met "software specifications," which suggests an internal, design-based ground truth rather than clinical ground truth like pathology or outcomes data. For the integrated "MR Prostate AI" algorithm, clinical ground truth would have been established for its separate 510(k) submission. |
| 8. Sample size for the training set | Not applicable/Not provided for this submission. The document describes internal non-clinical V&V for the syngo.MR Applications software. It does not refer to a machine learning model's training set within this context. The "Prostate MR AI" algorithm, being independently cleared, would have its training set details in its specific 510(k) dossier (K241770), not here. |
| 9. How the ground truth for the training set was established | Not applicable/Not provided for this submission. As above, this document does not discuss a training set or its ground truth establishment for syngo.MR Applications. This information would pertain to the Prostate MR AI algorithm and be found in its own 510(k). |
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(181 days)
VXvue is intended to acquire Digital images from X-ray Detectors, process the images to facilitate diagnosis and to display, and transfer the resulting images to other devices for diagnostic purpose.
VXvue is indicated for use in general radiographic images of human anatomy. And it is not for fluoroscopic, angiographic, and mammographic applications.
VXvue gets images from a detector, processes, and transfers the images and manages patient's information and the images for radiologists. VXvue enables images such as x-ray images to be stored electronically and viewed on screens.
VXvue offers full compliance with DICOM (Digital Imaging and Communications in Medicine) standards to allow the sharing of medical information with other PACS (Picture Archiving and Communication System Server). Besides, VXvue is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation and enhancement.
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(168 days)
Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, treatment planning, and production of an output file.
The Acorn 3D Segmentation module is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn 3D Segmentation is also intended for measuring and treatment planning. The Acorn 3D Segmentation output can also be used for the fabrication of physical replicas of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.
The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients.
Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judgment.
Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn 3D Software for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn 3D Software is structured as a modular package.
This includes the following functionality:
- Importing medical images in DICOM format
- Viewing images and DICOM data
- Selecting a region of interest using generic segmentation tools
- Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms
- Verifying and editing a region of interest
- Calculating a digital 3D model and editing the model
- Measuring on images and 3D models
- Exporting 3D models to third-party packages
- Planning pedicle screw placement
The Acorn 3D Segmentation module contains both machine learning based auto segmentation as well as semi-automatic and manual segmentation tools. The auto-segmentation tool is only intended to be used for thoracic and lumbar regions of the spine (T1-T12 and L1-L5) and the pelvis (sacrum). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal anatomy.
| Automatic | Semi-Automatic | Manual | |
|---|---|---|---|
| Definition | Algorithmic with little or no direct human control | A combination of algorithmic and direct human control | Directly controlled by a human |
| Tool Type | Machine Learning algorithm used to automatically segment individual vertebrae and the pelvis | Algorithmic based tools that do not incorporate machine learning. | Manual tools requiring user input. |
| Anatomical Location(s) | Spinal anatomy:• Thoracic (T1-T12)• Lumbar (L1-L5)• Sacrum | Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular | Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular |
Acorn 3DP Model is an additively manufactured physical replica of the virtual 3D model generated in Acorn 3D Segmentation. The output file from Acorn 3D Segmentation is used to additively manufacture the Acorn 3DP Model.
The Acorn 3D Trajectory Automation module contains dedicated fully automatic algorithms for planning pedicle screw trajectories. The algorithms are only intended to be used for the thoracic and lumbar regions of the spine (T1-T12 and L1-L5). The output file from Acorn 3D Trajectory Automation contains information relevant to pedicle screw placement surgery, including entry points, end points, and screw sizes of planned screws.
The provided FDA 510(k) clearance letter describes the Acorn 3D Software, specifically focusing on the new Acorn 3D Trajectory Automation module. However, the document is quite sparse on detailed descriptions of the acceptance criteria and the specifics of the study proving the device meets these criteria. The information below is extracted from the provided text, and where details are missing, it's explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "deviations were within the acceptance criteria" without specifying the numerical acceptance criteria themselves. It also doesn't provide specific numerical results of the device's performance, only a qualitative statement of accuracy.
| Acceptance Criteria (Not explicitly stated in numerical terms) | Reported Device Performance |
|---|---|
| Accuracy of pedicle screw geometry: Deviations within acceptance criteria | Deviations were within the acceptance criteria. |
| Accuracy of pedicle screw trajectories: Deviations within acceptance criteria | Deviations were within the acceptance criteria. |
| Substantial equivalence to predicate device for planning pedicle screws and trajectories | Performance testing demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "clinical data" was used.
- Data Provenance: Not specified. It's unclear if the clinical data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not mention that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone Performance Study
- Yes, a standalone performance study was done for the Acorn 3D Trajectory Automation module. The document states:
- "The accuracy of pedicle screw geometry as well as pedicle screw trajectories created in the subject device, Acorn 3D Trajectory Automation, was assessed via bench testing."
- This implies the algorithm's performance was evaluated independently without human intervention during the trajectory planning process itself, as it's a "fully automatic algorithm."
7. Type of Ground Truth Used
- The ground truth for the "accuracy of pedicle screw geometry" and "pedicle screw trajectories" was established by comparing the device's output to "clinical data." While the nature of this "clinical data" is not explicitly defined (e.g., expert consensus on images, surgical outcomes, or pathology reports), it serves as the reference standard.
8. Sample Size for the Training Set
- The document does not specify the sample size used for the training set of the machine learning algorithms. It mentions "Using a collection of images and masks as a training dataset for machine-learning segmentation algorithm" but no numbers.
9. How the Ground Truth for the Training Set Was Established
- The document states that the machine learning segmentation algorithm uses "a collection of images and masks as a training dataset." It doesn't explicitly describe how these "masks" (which represent the ground truth segmentations) were created. It can be inferred that these masks would have been generated by human experts, likely through manual or semi-automatic segmentation, but this is not confirmed in the text.
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(77 days)
The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.
The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection.
Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.
The TheraSphere 360 Y-90 Management Platform is an end-to-end, browser-based platform that will host a wide range of resources (e.g. radioembolization activity calculations, ordering, tracking, and education) that support Authorized Users of TheraSphere Microspheres.
The TheraSphere 360 Platform includes treatment planning functionality, activity calculation functionality, vial selection and ordering, and post-treatment analysis functionality. The treatment planning functionality and the activity calculation functionality include an interactive tool intended for calculating the activity of TheraSphere Microspheres required at the treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.
The Vial Selector function allows users to select and order TheraSphere Microspheres dose vials from inventory that match desired results.
The post-treatment analysis functionality is intended as an optional tool for post-treatment evaluation following TheraSphere Microspheres treatment.
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(202 days)
Sirona Advanced Imaging Suite is a Medical Image Management and Processing System and consists of four PET (Positron Emission Tomography) viewing features which is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: PET and CT.
These features are as follows:
- a. PET-CT overlay/fusion
- b. Measurement of Standardized Uptake Value on PET image series and generated PET-CT overlay/fusion
- c. Maximum Intensity Reconstruction of PET image series
- d. Multiplanar Reconstruction of PET image series and PET-CT overlay/fusion
Sirona Advanced Imaging Suite is intended to be used with the Sirona PACS (or MIMPS) Viewer.
The intended users of the PET Module are trained radiologists, medical professionals, or other healthcare providers within a healthcare organization.
Sirona Advanced Imaging Suite is a software-based imaging solution designed to facilitate the review, analysis, and interpretation of positron emission tomography (PET) and computed tomography (CT) imaging studies. Intended to be used with the Sirona PACS (or MIMPS) Viewer, this module enables healthcare professionals, including radiologists and nuclear medicine physicians, to visualize, manipulate, and analyze multi-modality medical images for diagnostic and clinical decision-making. Sirona Advanced Imaging Suite provides image fusion and co-registration capabilities, allowing users to overlay PET and CT images for combined anatomical and functional assessment. It supports multi-planar reconstructions (MPRs), maximum intensity projections (MIP), and standardized uptake value (SUV) calculations for metabolic activity assessment. The software is fully compatible with DICOM standards, ensuring seamless integration with imaging modalities and healthcare IT infrastructure.
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(70 days)
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning.
The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- Viewer 5.4.2 (General Viewing)
- Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
Universal Atlas Performer
Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer
Software that provides medical image data auto-segmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then "cloned" into the virtual image space of connected mixed reality glasses. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
The provided document describes the FDA 510(k) clearance for Brainlab AG's Viewer device. However, it explicitly states, "Viewer is not intended for diagnosis nor for treatment planning." This means the device primarily focuses on image display, manipulation, and basic measurements rather than making diagnostic or clinical decisions.
As such, the performance data presented is related to technical functionality and accuracy of measurements rather than diagnostic accuracy against a ground truth for a medical condition. Therefore, many of the requested sections regarding diagnostic performance, ground truth, experts, and comparative effectiveness studies are not applicable in the context of this specific regulatory submission.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
Given the nature of the device (medical image management and processing system, not for diagnosis), the acceptance criteria and performance reported are largely functional and technical.
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance/Outcome |
|---|---|---|
| Software Functionality | Successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing, cybersecurity tests. (General V&V) | Passed: Documentation indicating successful completion of these tests was provided, as recommended by FDA guidance. (Enhanced level) |
| Ambient Light Test | Determine Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions. | Passed: The display quality was determined to be sufficient. (Specific results not detailed beyond "sufficient visualization") |
| Hospital Environment Tests | Test compatibility of the Subject Device with various hardware platforms and compatible software. | Passed: Compatibility was confirmed. (Specific platforms/software not detailed) |
| Display Quality Tests | Measure and compare optical transmittance, luminance non-uniformity, and Michelson contrast of the head-mounted display (Magic Leap 2) to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. Tests were conducted with and without segmented dimming. | Passed: The tests ensured seamless integration, high visibility, and image quality. (Specific numerical results not detailed, but the outcome implies they met internal quality standards). |
| Measurement Accuracy Test | Inexperienced test persons (3) able to place distance measurements using a Mixed Reality user interface (Magic Leap controller) with a maximal deviation of less than one millimeter in each axis compared to mouse and touch on desktop as input methods. | Passed: The test concluded that the specified accuracy was achieved, meaning the maximal deviation was less than one millimeter. |
Study Details
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Sample size used for the test set and the data provenance:
- Measurement Accuracy Test: 3 inexperienced test persons. No information on the number of measurements or specific datasets used.
- Other Tests (Ambient Light, Hospital Environment, Display Quality): The sample sizes for these bench tests are not explicitly stated in terms of patient data or specific items tested, but represent functional validation of the system and its components.
- Data Provenance: Not applicable for the described functional and accuracy tests. The device deals with DICOM data, but the specific source of that data for these tests is not mentioned as the tests focus on the device's capabilities rather than clinical diagnostic performance on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Measurement Accuracy Test: No experts were explicitly mentioned for establishing "ground truth" for the measurement accuracy test. The comparison was between different input methods (Magic Leap controller vs. mouse/touch). The "ground truth" for these measurements would likely be the known distances within the virtual environment or the established accuracy of the mouse/touch methods themselves, assumed to be accurate. The "inexperienced test persons (3)" were the subjects performing the measurements, not experts establishing ground truth.
- Other Tests: Not applicable, as these were functional and technical performance tests not involving clinical ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests described are bench tests and functional validations, not clinical studies requiring adjudication of findings.
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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 was done or is applicable. This device is cleared as a "Medical Image Management And Processing System" and explicitly states it is "not intended for diagnosis nor for treatment planning." Therefore, there is no AI assistance for human readers in a diagnostic context described, and no effect size would be reported.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the conventional sense of a diagnostic algorithm. The device's core function is to display and manipulate images with some basic automated measurements. The measurement accuracy test (3D measurement placement) involves human interaction with the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the Measurement Accuracy Test, the ground truth appears to be based on the established accuracy of desktop input methods (mouse and touch) for placing measurements, and the expectation of how accurately the mixed reality controller should perform relative to those. It is not an expert consensus on a clinical condition, pathology, or outcomes data.
- For other tests (Ambient Light, Hospital Environment, Display Quality), the "ground truth" refers to engineering specifications and visual quality standards.
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The sample size for the training set:
- Not applicable. This document describes a software update and clearance for an image viewing and manipulation device, not an AI/ML algorithm that requires a "training set" for diagnostic or predictive tasks.
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How the ground truth for the training set was established:
- Not applicable, as there was no training set mentioned.
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(93 days)
Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. Enterprise Imaging Desktops are intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.
MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling, image registration and segmentation can be used to enhance image viewing. Automatic spine labelling provides the capability to semi-automatically label vertebrae or disks.
As a comprehensive imaging suite, Enterprise Imaging Desktops integrates with servers, archives, Radiology Information Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records (EPR), reporting and 3rd party applications for customer specific workflows.
Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
When deployed as a hospital-wide Solution (Enterprise Imaging for Multispecialty Departments), Agfa HealthCare's Enterprise Imaging Desktops provides order generation, image acquisition, quality control, image reading, reporting, and review workflows for departments that have no such systems available including (but not limited to) dermatology, ophthalmology, gastroenterology, dental and general hospital use.
AGFA HealthCare's Enterprise Imaging XERO Viewer is a software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
This premarket notification is for AFGA HealthCare's Enterprise Imaging - Vessel Tracking functionality. The Vessel Tracking functionality is available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product.
Enterprise Imaging is a standalone software device (SaMD). AGFA HealthCare Enterprise Imaging Vessel Tracking functionality provides the capability to automatically create vessel centrelines, read the contour points and angles as well as provide minimum and maximum diameter of cross sections.
AGFA HealthCare's Enterprise Imaging Desktops is a medical image management and processing system (MIMPS), product code LLZ, which provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
AGFA HealthCare's XERO Viewer is a medical image management and processing system (MIMPS), product code LLZ, which is a web based software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents. XERO Viewer enables healthcare professionals to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer.
AGFA HealthCare's Enterprise Imaging Vessel Tracking adds the following new functionality available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product: a vessel analysis tool that provides the capability to automatically create vessel centrelines that can be used to monitor and analyze the progression of vascular diseases.
Vessel tracking is new functionality not included in the previous 510(k) clearances for Enterprise Imaging Desktops and Enterprise Imaging XERO Viewer. The vessel tracking algorithm however was previously included in AGFA HealthCare's IMPAX Volume Viewing 3.0 510(k) primary predicate K133135. The new device is substantially equivalent to the primary predicate device's (K133135) vessel analysis functionality.
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(160 days)
ProKnow DS is intended to be a data archive and processing software which supports review, analytics, and clinical decision-making with a focus on the data specific to radiation oncology patients.
ProKnow DS should be used in healthcare facilities by trained medical professionals including, but not limited to physicians, medical technologists, physicists and dosimetrists.
ProKnow DS provides a high-performance, scalable medical image management and processing system. It allows users to archive, inspect, analyze, and interact with radiation therapy patient data for both retrospective and prospective studies. Its features are centered on two primary areas of interaction: (1) single patient datasets and (2) collections of patient datasets, i.e., patient cohorts. Users are able to import patient data from existing imaging, contouring, and treatment planning systems (via DICOM formats). Once imported, patient data is archived for long-term storage and is also available for inspection and analysis (examples of supported inspection and analysis tasks include: visualizing images, structures, and dose distributions; inspecting plan information; inspecting dose volume histograms; and extracting metrics).
ProKnow DS also allows users to edit physical models associated with a patient for use in retrospective studies or to be exported to commercially available radiation treatment planning systems. Once a set of patients have been established in ProKnow DS, users may create collections of related patients allowing them to analyze and correlate dosimetric values of interest and clinical endpoints across large treatment populations.
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