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The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area. It is indicated for diseases of the trachea and bronchi other than contraindications. The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use. The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit. The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device. The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient. The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area. This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc. This product contains a working channel, which is convenient for use after insertion of endoscopic accessories. The applied part of this product is the insertion part of the Single-use Bronchoscope. Single use application of this product minimises the risk of cross-contamination of the patient.

Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR is used to acquire/Process/Display/Store/Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screener CR system is used. Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.

The Wireless/ Wired X-Ray Flat Panel Detectors are designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (CsI). The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission. Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR", runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes: 1. User Login 2. Display Connectivity status of hardware devices like detector 3. Patient entry (Manual, Emergency and Worklist) 4. Exam entry 5. Image processing 6. Search patient Data 7. Print DICOM Image 8. Exit

The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.

The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung. The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff). The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters. The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr. The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.

The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only. Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor. The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced. The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits. The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.

SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.

SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. The device only processes DICOM images for the end User and is intended to be used by radiology technologists in an imaging center, clinic, or hospital. The device's inputs are MRI images in DICOM format. The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The deep learning algorithm performs noise reduction with the ability of adjusting the denoising level 0 to level 8, and sharpening filter performs the sharpening function with the ability of adjusting the sharpness level from level 0 to level 5. SwiftMR provides an automatic image quality enhancement function for MR images acquired in various environments. SwiftMR can only be used for professional purposes and is not intended for use on mobile devices.

QRS Dental Implants Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. The implants (Ø3.3mm and one-piece) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

QRS Dental Implants are self-tapping, root-form, one piece or two piece screw (Red Class, Blue Class and Gold Class) type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The QRS' dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The QRS' two piece implant is to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation. QRS dental implants (Red Class, Blue Class and Gold Class) are designed with a standard internal hexagon system and provided in 3.3, 3.75, 4.2, 5.0 and 6.0mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. QRS dental implant one-piece is provided in 3.3 and 3.5mm diameter for lengths of 10, 11.5, 13 and 16mm. The ORS' two piece dental implants are to be used in combination with cover screws. healing caps, abutments, smart attachment and straight multi-unit abutment according to commonly used protocol in the dental implantation field. The QRS Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The implants are grit blasted and acid etched surface. All QRS' abutments, cover screws, healing caps, Straight ball attachment, smart attachment and strait multi- unit abutments are made of Ti6A14V ELI titanium alloy complying with ASTM F 136-13: Wrought Titanium-6 Aluminum -4Vanadium ELI alloy for surgical implant applications and ISO 5832-3: 2016: Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. Abutments (straight abutments, angulated abutments (15°, 25°), and anatomic angulated abutments (15°, 25°)) are intended to be used in conjunction with endosseous dental implants fixture to aid in prosthetic rehabilitation. The abutments are intended for long term use and are in contact with tissue. The abutments are available straight or angulated, in different heights and diameters to accommodate the patient's specific needs. They are available in 0, 15 or 25 degrees angulation. Straight Abutment SP Titanium Abutment is provided in height of 5, 7 and 9mm. Standard shoulder abutment in heights of 1, 2, 3 and 4mm Standard Wide Shoulder Abutment is provided in heights of 1, 2, 3 and 4mm Standard 15° Abutment is provided in heights of 2, 3 and 4mm Standard 25° Abutment is provided in heights of 2, 3 and 4mm The healing caps are intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Healing Caps are provided in 4.5 diameter in heights of 3, 4, 5, 6 and 7mm. Wide Healing Cap is provided in 6 diameter in heights 3, 4, 5 and 6mm. Straight Ball attachment are designed to increase retention of (partial) overdentures, supported on implants. QRS titanium Ball Attachments provide firm retention and stabilization of the overdenture when used with tissue-supported implant-retained overdentures and are compatible with QRS internal hexagon connection implants. Straight ball attachments are provided in heights of 2, 3, and 4mm Smart Attachment - Locator abutments are designed for use with overdentures or partial dentures retained in whole or in part by dental implants in the mandible or maxilla. They offer multiple levels of retention and low vertical profile. The selfaligning design enables patients to easily seat their dentures. Smart attachment are provided with heights of 1, 2, 3 and 4mm. Straight Multi-unit abutment are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-unit abutments are provided in heights of 2, 3, 4 and 5 mm. Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit abutment are provided non-sterile to the user and have to be sterilized prior to use by moist heat All the Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit are intended for single use only. QRS Implants are especially designed for implantation in a wide range of bone types and bone augmentation procedures. Each two piece implant is supplied with a cover screw, which is intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Maximum compatibility and accuracy can be achieved when using compatible QRS tools, drills, accessories and prosthetic parts manufactured by QRS.

Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.

Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for nongrid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxy sulfide (GOS). The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission. Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR, runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes: - 1. User Login - 2. Display Connectivity status of hardware devices like detector - 3. Patient entry (Manual, Emergency and Worklist) - 4. Exam entry - 5. Image processing - 6. Search patient Data - 7. Print DICOM Image - 8. Exit

The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain. spine, knee, ankle, shoulder and hip MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MR images. SwiftMR is not intended for use on mobile devices.

SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. The device only processes DICOM images for the end User and is intended to be used by radiology technologists in an imaging center, clinic, or hospital. The device's inputs are standard of care MRI images in DICOM format. The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The deep learning algorithm performs the denoising function and sharpening filter performs the sharpening function with the ability of adjusting the sharpness level from level 0 to level 5. SwiftMR provides an automatic image quality enhancement function for MR images acquired in various environments. SwiftMR can only be used for professional purposes and is not intended for use on mobile devices. SwiftMR 's automation procedure is as follows: - . Receive MR images that are in DICOM format - . Image quality enhancement using Deep Learning model and sharpening filter - Transfer enhanced MR image as DICOM format to PACS . There are four deep learning algorithms: three are for the general pulse sequences and the other one is for the TOF pulse sequences. The four deep learning algorithms share the same network architecture, input and label data generation method, training procedures. The only difference between the four deep learning algorithms is the input / label dataset used for training. After integration with the facilities PACS, SwiftMR performs image processing in the background automatically. At the same time, SwiftMR allows logged-in users to use its functions and view the processing status. When loqged in as the System Admin, the function is available to the control automation procedure and system change settings. On the User side, the User can retrieve the results of image processing in the form of a worklist by login to the user account. The software provides three main functions, which are image processing, quality check and progress monitoring. The software is intended to run automatically in the background so that it does not interrupt the workflow of users. When the user executes MR scans as he/she usually does, the newly acquired images are automatically uploaded to the server and registered in the database (DB) for image processing. Once image processing is complete, the images are sent to PACS. If the user wishes to monitor this automated workflow to check on the status of image processing, he/she can check the main page of the client application or toast messages will appear on the bottom right corner upon completion of each processing. After using the software, they should log out for security reasons. A settings menu is provided in the form of a user interface to enable system admin to modify software settings as required by the institution or respective user.

The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindication: Exposure of X-Ray should be avoided during pregnancy.

The Cardiovascular Angiography system is designed to perform fluoroscopic & digital radiographic studies and are used in interventional examinations. This system covers the complete range of angiographic applications, cardiac angiography, neuroangiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and digital radiographic/ fluoroscopic procedures. The following components are configured to create the Cardiovascular Angiography system: - 1. Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima FDX) or Mobile C-Arm (Digiscan FDX-VXXYY), X-ray tube assembly and Solid State X-Ray image detector - 2. Patient Table - 3. Ceiling suspended display(s) - 4. Footswitch for releasing radiation - 5. Control console for controlling the stand, patient table, collimator and imaging system.