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510(k) Data Aggregation

    K Number
    K221892
    Device Name
    VISIONAIR
    Manufacturer
    PacificMD Biotech Llc
    Date Cleared
    2022-10-05

    (98 days)

    Product Code
    BXQ, EOB
    Regulation Number
    868.1800
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
    Device Description
    The VISIONAIR™ software can be utilized to automatically measure the cross-section area of the Internal Nasal Valve (INV) and Nasal Cavum (NV) and measure the nasal respiratory airway in this region of the anatomy. The VISIONAIR™ system consists of the following components: - The VISIONAIR™ algorithm which performs the Internal Nasal Valve and Nasal Cavum cross-section area segmentations. - The VISIONAIR™ Graphical User Interface (GUI) used for data entry, view the endoscopic image from third party endoscopes and display the data analysis to the user. - A smart device such as tablet or laptop which runs on Windows 10 or a later operating system with the VISIONAIR™ application installed. - A cloud service that runs in the background and can be activated by the user when a particular dataset for a case is desired to securely and anonymously be stored to the Cloud Server (REAI). - USB memory used to encrypt and anonymize the patient information, whether the data is stored locally or to the cloud, and stores the credits needed to activate the VISIONAIR™ software for each case. The VISIONAIR™ application interfaces with third-party endoscopic systems via the ports located on the smart device. The smart device ports enable the third-party systems endoscopic video display to be streamed on the VISIONAIR™ application endoscopic video display. In this 510(k) submission, a FDAcleared endoscope (K970247) was selected as the reference device to support the scientific methodology. The VISIONAIR™ application automatically analyzes the endoscopic images using its trained AI algorithm to measure the nasal valve and nasal cavum surface areas. The VISIONAIR™ application also provides a database file system to manage the data and interface securely and anonymously with the cloud server via the REAl module.
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    K Number
    K170071
    Device Name
    SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
    Manufacturer
    Sleep Group Solutions
    Date Cleared
    2017-11-09

    (304 days)

    Product Code
    BXQ, BXO
    Regulation Number
    868.1800
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECCOVISION™ is intended to measure the upper respiratory airway by means of acoustic reflection.
    Device Description
    The Eccovision™ device is used to obtain an objective measurement of the upper respiratory airway. The device uses acoustic signal processing technology to provide graphical representation of the airway patency as a function of distance from the airway opening. The system consists of a control unit (which connects to customer owned personal computer), and software application, wave tube (one each for the Pharyngometer and Rhinometer) and electronic platform, mouthpieces and nose tips and filter strips. The device performs a dynamic test that determines the dimension of the oral airway past the glottis while the patient is breathing thorough either the mouthpiece or nose tip. A customer provided computer with the loaded Eccovision™ application software then processes the incident and reflected sound signals provides an area-distance curve representing the lumen together with minimal crosssectional area and volume. A measurement is obtained by passing a signal along a probe positioned in the mouth or nose then recover a signal by use of two (2) microphones in the wave tube. The signal is processed by the software and displayed on a screen or relayed to a printer, detailing the cross-sectional area of the airway as a function of distance from the teeth.
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    K Number
    K092611
    Device Name
    SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
    Manufacturer
    SONARMED, INC.
    Date Cleared
    2010-04-28

    (245 days)

    Product Code
    OQU
    Regulation Number
    868.5730
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonarMed™ AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT. The SonarMed AMS is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AMS is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-alone diagnostic system. It is intended for use with patients who use ET tube sizes from 6.5 mm to 9.0 mm, with a body weight of >35 kg.
    Device Description
    The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a sterile, single-use SonarMed Adapter (Adapter) and software that operates the Monitor and Adapter. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Adapter is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator. Using sonic reflection technology, signals from the Adapter allow the color LCD on the Monitor to display to a clinician: The baseline location of the ETT tip as established by the clinician Quantification of passageway diameter relative to the ETT diameter (for example a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus) ETT movement relative to the baseline location ETT occlusion / obstruction information including percent obstructed The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's color LCD. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
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    K Number
    K022311
    Device Name
    RHINOSTREAM RHINOMANOMETER MODULE
    Manufacturer
    RHINOMETRICS A/S
    Date Cleared
    2002-10-04

    (79 days)

    Product Code
    BXQ
    Regulation Number
    868.1800
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Rhinomanometer is a medical instrument, intended to measure nasal airway pressure up to 5 centimeters H2O. (500Pa) and air flow up to 1000 ml/s. (2001 a) and in the now ap to roove. which is useful to the physician in studying the nasal decongestion of the nasal This is a not it as re procedures, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.
    Device Description
    The RhinoStream Rhinomanometer module is designed to objectively and quickly measure and quantify a dynamic measure of the patient ability breath through the nasal airway passages.
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    K Number
    K972140
    Device Name
    A1 ACOUSTIC RHINOMETER
    Manufacturer
    G.M. INSTRUMENTS LTD.
    Date Cleared
    1998-09-30

    (481 days)

    Product Code
    BXQ
    Regulation Number
    868.1800
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Objective measurement device in "blocked nose" situations Deviated septums e.g. Allergic rhinitis Enlarged adenoids With the possibility of absolute and pre/post surgical or treatment comparisons.
    Device Description
    A1 Acoustic Rhinometer
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