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510(k) Data Aggregation

    K Number
    K243146
    Device Name
    iCare APP
    Manufacturer
    iHealth Labs, Inc.
    Date Cleared
    2025-02-03

    (126 days)

    Product Code
    MWI, DXN, OCH, OUG, PUH
    Regulation Number
    870.2300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team. The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
    Device Description
    The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team. iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
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    K Number
    K241728
    Device Name
    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
    Manufacturer
    Murata Vios, Inc.
    Date Cleared
    2025-01-23

    (223 days)

    Product Code
    DXN, DPZ, DQA, DRG, DRT, DXJ, OUG
    Regulation Number
    870.1130
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
    Device Description
    The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW. VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.
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    K Number
    K232354
    Device Name
    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
    Manufacturer
    Murata Vios, Inc.
    Date Cleared
    2024-03-22

    (228 days)

    Product Code
    DRT, DPZ, DQA, DRG, DSI, DXJ, MHX, OUG
    Regulation Number
    870.2300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters. VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions. The Vos CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.
    Device Description
    The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,
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    K Number
    K233024
    Device Name
    Alma Harmony
    Manufacturer
    Alma Lasers, Inc.
    Date Cleared
    2024-02-08

    (139 days)

    Product Code
    GEX, ILY, ONF
    Regulation Number
    878.4810
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). Clear Skin Pro 1540nm Applicator: The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. SupErb 2940nm Applicator: The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers. General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated. Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon. Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy. Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia. Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit. Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy. Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator 1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. 532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology. ClearVas Nd:YAG 1064nm For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. Treatment of wrinkles. Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V). Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology. The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations. Use on all skin types (Fitzpatrick I-VI). Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature. For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. Iris Diode Applicator The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
    Device Description
    The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface. In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).
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    K Number
    DEN220073
    Device Name
    Revi System
    Manufacturer
    BlueWind Medical Ltd.
    Date Cleared
    2023-08-16

    (315 days)

    Product Code
    QXM, OXM
    Regulation Number
    876.5305
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
    Device Description
    The Revi System is a tibial neuromodulation system that consists of the following four different components: 1. Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source. 2. Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired. 3. Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection. 4. HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).
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    K Number
    K230371
    Device Name
    The Alma Soprano Titanium
    Manufacturer
    Alma Lasers Inc.
    Date Cleared
    2023-02-22

    (9 days)

    Product Code
    GEX, ILY, OUG
    Regulation Number
    878.4810
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. 810nm Applicator Soprano Titanium 810 nm applicator intended use and indications for use: The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include: • The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) 755nm applicator Soprano Titanium 755 nm applicator intended use and indications for use: The indications for use for the 755nm Diode Laser Module include: • The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. · Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes) NIR Applicator NIR Applicator intended use and indications for use The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are: - · Elevating the tissue temperature for the temporary relief of minor muscle pain and stiffness, - · The temporary relief of minor joint pain associated with arthritis, - · The temporary increase in local circulation where applied, and - · The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    The Alma Lasers Soprano Titanium Laser System consists of: - System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts) - Operator control panel with touch screen technology (GUI) - 810 nm applicator ● - 755 nm applicator - Small NIR applicator - Trio 4 cm2 applicator ● - Trio 2 cm2applicator .
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    K Number
    K193512
    Device Name
    THD Procto Software System
    Manufacturer
    THD SpA
    Date Cleared
    2020-01-26

    (39 days)

    Product Code
    IYO, FWG, ITX, OUG
    Regulation Number
    892.1560
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THD Procto Software is a software that can be used: · In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image. · In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol
    Device Description
    The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for: - Endoanal ultrasound (→ trans-rectal ultrasound / echography) - - -Anoscopy exams, During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; Durinq Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camera; The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below: - Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below - . Endoanal Ultrasound Module, which manages: - The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video - Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing, - The examination report (medical history, comments, conclusions) and the printing O - Anoscopy Exams module, which manages: - Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen - Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing - The examination report (medical history, comments, conclusions) and the printing o
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    K Number
    K183387
    Device Name
    M3290B Patient Information Center iX
    Manufacturer
    Philips Medical Systems
    Date Cleared
    2019-08-06

    (243 days)

    Product Code
    MHX, DSH, DSI, MLD, MSX, OUG
    Regulation Number
    870.1025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Philips Patient Information Center iX software application is to: - Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients. - . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition. - Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2. - Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices. - Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices. - Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. - Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use. Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.
    Device Description
    The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database. Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors. Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.
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    K Number
    K183691
    Device Name
    PENTAX Medical ENT Video Imaging System
    Manufacturer
    PENTAX of America, Inc.
    Date Cleared
    2019-06-12

    (163 days)

    Product Code
    EOB, EQL, OUG, PEA
    Regulation Number
    874.4760
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscopes, PENTAX Medical Video Processor, PENTAX Medical Digital Video Capture Module, PENTAX Medical Laryngeal Strobe and other ancillary equipment. 1) PENTAX Medical Video Naso-Pharyngo-Laryngoscope The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) is intended to be used with a PENTAX Medical Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. 2) PENTAX Medical Video Processor The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, PENTAX Medical VNL-1570STK, VNL8-10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and naso-pharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.
    Device Description
    PENTAX Medical ENT Video Imaging System is used for ENT endoscopic observation and nasopharyngolaryngoscopic (ENT) diagnosis, treatment, and video observation. The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor. The primary components of the system include the following: - PENTAX Medical Video Processor EPK-i5010 - PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-1570STK - PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series) - PENTAX Medical Laryngeal Strobe 9400 - PENTAX Medical Digital Video Capture Modules (two models are available: 9310HD/937HD)
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    K Number
    K182637
    Device Name
    Philips IntelliVue XDS Software
    Manufacturer
    Philips Medizin Systeme Boeblingen GmbH
    Date Cleared
    2019-04-26

    (214 days)

    Product Code
    MSX, DSH, OUG
    Regulation Number
    870.2300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelli Vue XDS Software is intended for use as an additional, independent display for viewing screens, generated by specified network-connected Philips patient monitors. The IntelliVue XDS Software alone is not intended for remotely monitoring patients without caregivers in vicinity (unattended patients). It is indicated for local and remote operation of these Philips patient monitors. It is indicated for printing reports as generated by these Philips patient monitors. It is indicated to be used by trained healthcare professionals. Rx Only: Caution, U.S. Federal Law restricts this device to sale by or on the order of a physician.
    Device Description
    The IntelliVue XDS Software (867019) is a bedside information system. The IntelliVue XDS Software provides network services, printing services, patient monitor remote display services, launch pad services, input device sharing services and XDS database services. The IntelliVue XDS Software can be connected to one or more specified Philips patient monitors and allows the remote viewing of the patient monitor generated data. Depending on the configuration, the remote operation of the network-connected patient monitor with standard off-the shelf information technology equipment input devices (touch screen, keyboard, and mouse) is also supported. The IntelliVue XDS software does not modify or alter the Philips specified patient monitor. nor does it generate any data on its own. It is solely displaying the patient monitor generated data. It also displays the current alarm and INOP states for the patient, but does not provide an auditory alarm signal announciation function. The IntelliVue XDS Software is not a primary monitoring or alarming device. The IntelliVue XDS Software is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
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