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510(k) Data Aggregation

    K Number
    K250058
    Device Name
    NEAT 001
    Manufacturer
    Brain Electrophysiology Laboratory Company, LLC
    Date Cleared
    2025-04-10

    (90 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brain Electrophysiology Laboratory Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Automatic scoring of sleep EEG data to identify stages of sleep according the American Academy of Sleep Medicine definitions, rules and guidelines. It is to be used with adult populations.
    Device Description
    The Neurosom EEG Assessment Technology (NEAT) is a medical device software application that allows users to perform sleep staging post-EEG acquisition. NEAT allows users to review sleep stages on scored MFF files and perform sleep scoring on unscored MFF files. NEAT software is designed in a client-server model and comprises a User Interface (UI) that runs on a Chrome web browser in the client computer and a Command Line Interface (CLI) software that runs on a Forward-Looking Operations Workflow (FLOW) server. The user interacts with the NEAT UI through the FLOW front-end application to initiate the NEAT workflow on unscored MFF files and visualize sleep-scoring results. Sleep stages are scored by the containerized neat-cli software on the FLOW server using the EEG data. The sleep stages are then added to the input MFF file as an event track file in XML format. Once the new event track file is created, the NEAT UI component retrieves the sleep events from the FLOW server and displays a hypnogram (visual representation of sleep stages over time) on the screen, along with sleep statistics and other subject details. Additionally, a summary of the sleep scoring is automatically generated and added to the same participant in the FLOW server in PDF format.
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    K Number
    K241513
    Device Name
    Sourcerer
    Manufacturer
    Brain Electrophysiology Laboratory Company, LLC
    Date Cleared
    2024-09-27

    (121 days)

    Product Code
    OLX
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brain Electrophysiology Laboratory Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The software is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 16 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.
    Device Description
    Sourcerer is an EEG source localization software that uses EEG and MRI-derived information to estimate and visualize cortex projections of human brain activity. Sourcerer is designed in a client-server model wherein the server components integrate directly with FLOW - BEL's software. Inverse source projections are computed on the server using EEG and MRI data from FLOW using the Electro-magnetic Inverse Module (EMIM API). The inverse results are interactively visualized in the Chrome browser running on the client computer using the Electro-magnetic Functional Anatomy Viewer (EMFAV).
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    K Number
    K193390
    Device Name
    CS Model+
    Manufacturer
    Trophy
    Date Cleared
    2020-04-02

    (118 days)

    Product Code
    PNN
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trophy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
    Device Description
    CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility. CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including: - -Intraoral scanners; - -Extraoral devices with 3D object modality. CS Model+ allows healthcare professionals to do the following: - -Display digital 2D or 3D views of digital 3D models; - Adjust the color and opacity of digital 3D models; - - -Make indicative measurements of digital 3D models; - Print and export images of digital 3D models; - - -In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations; - -Generate an orthodontic report; - Create virtual setups; - - -Automatically generate virtual setups suitable for aligners treatment; - Make automatic and customizable export of virtual models; - - -Manage the intermediate steps; - -Make refinement during treatment.
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    K Number
    K200183
    Device Name
    CS 9600
    Manufacturer
    Trophy
    Date Cleared
    2020-03-13

    (49 days)

    Product Code
    OAS, MUH
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trophy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
    Device Description
    CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment. CS 9600 is a cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region. Additional features such as low dose mode, scout image and metal artifact reduction are also provided by the CS 9600. The CS 9600 can also be upgraded with cephalometric modality. The cephalometric modality of the proposed device CS 9600 is the same than the one available in the reference device K151087. The cephalometric mode works with a narrow beam linear scanning process called a "slot technique". The patient head is scanned in lines with a flat, fan-shaped x-ray beam.
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    K Number
    K181136
    Device Name
    CS 9600
    Manufacturer
    Trophy
    Date Cleared
    2018-05-24

    (24 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trophy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
    Device Description
    CS 9600 is an extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. CS 9600 is cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region. Additional features such as low dose mode, scout image, metal artifact reduction are also provided by the CS 9600.
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    K Number
    K173622
    Device Name
    CS Imaging
    Manufacturer
    Trophy
    Date Cleared
    2018-01-16

    (53 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trophy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.
    Device Description
    Not Found
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    K Number
    K171583
    Device Name
    RhythmView Workstation
    Manufacturer
    Abbott Electrophysiology
    Date Cleared
    2017-09-01

    (93 days)

    Product Code
    DQK, DOK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Electrophysiology

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters. It provides a dynamic, simplified representation of wave propagation. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K163709
    Device Name
    FIRMap Catheter
    Manufacturer
    ABBOTT ELECTROPHYSIOLOGY
    Date Cleared
    2017-02-28

    (60 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT ELECTROPHYSIOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
    Device Description
    The FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.
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    K Number
    K161240
    Device Name
    Rhythm View Workstation (non-streaming)
    Manufacturer
    Abbott Electrophysiology
    Date Cleared
    2016-08-10

    (100 days)

    Product Code
    DQK, 870
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Electrophysiology

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Software, Keyboard, Mouse, Two Port USB Switch, Solid State Hard Drive (optional component). RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K153093
    Device Name
    FIRMap Catheter
    Manufacturer
    ABBOTT ELECTROPHYSIOLOGY
    Date Cleared
    2016-04-07

    (164 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT ELECTROPHYSIOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.
    Device Description
    The catheter is used in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.
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