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The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.

The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer. The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer. The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable, batterypowered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery-powered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

The SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

The SoundBite® Crossing System - Peripheral (14P) is a recanalization tool, designed to help physician's placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite® Crossing System - Peripheral (14P) consists of the reusable mobile SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, and their respective accessories. The SoundBite® Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite® Active Wire 14P and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer. The SoundBite® Active Wire 14P is similar in construction to the 0.018" CTO crossing wire provided with the predicate device, with a friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.36 mm (0.014") and it is 300 cm long, with a working length of 145 cm. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. The single-use SoundBite® Active Wire 14P is supplied sterile with a shelf life of 24 months.

MOBILETT Elara Max is a mobile device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. MOBILETT Elara Max enables radio-graphic exposures of the whole body and may be used on pediatric. adult and bariatric patients. It can also be used for emergency applications. MOBILETT Elara Max is not indicated for mammographic imaging.

The MOBILETT Elara Max is a mobile X-ray system with a solid state x-ray imager (SSXI). The system is designed to provide X-ray imaging by healthcare professionals. Rechargeable batteries support cable less operation and motor-driven movements to the point of care. The mobile generator is positioned at bedside and the X-ray system is directed to the anatomical area to be imaged. The image detector is placed perpendicular to the central beam behind this anatomical area. The system features a collimator with a light field that mimics the x-ray field to limit the field of exposure to the area to be imaged. Exposure may be released via remote control. The image data acquired by the detector are send wireless to the mobile unit. The purpose of this submission is a new software version VF10, some minor hardware changes and the new device name MOBILETT Elara Max. The new software VF10 will introduce the following new features: - The operating system will be MS Windows 10 - New cybersecurity features - Additional pediatric programs - Implementing a "Virtual Machine" that supports hospital IT - The SSXIs have been updated - The EMC (Electromagnetic Compatibility was tested according to the IEC 4th edition) - The image processing algorithms (Diamond View MAX) will be used for exposures without grid. - The Mobilett Elara will be coated with an anti-microbial paint

The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography. The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact: 1. A new 43x35cm Wireless detector, 3543DR 1. 2. A new X-ray tube and a new generator 3. An optional 40 line grid with grid suppression algorithm 4. Wireless Remote Control Console 5. An optional All-in-one PC containing touch screen function 6. An optional positioning assistance camera 7. Upgrade software to VA10 8. Upgrade operator system from Windows XP to Windows 10

Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. Ysio Max is not for mammography examinations.

The Ysio Max is a stationary X-ray system for radiography. The main components are the X-ray generator, the X-ray tube with collimator supported by a ceiling rail system. The Ysio Max comes with SSXIs (Solid State X-ray Imagers) that can be mobile or fixed in the Bucky tray. An image processing and data management system (syngo FLC) completes the radiographic suite. The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features: - The operating system will be MS Windows 10 - New cybersecurity features - Additional pediatric programs - Implementing a "Virtual Machine" that supports hospital IT - The SSXIs have been updated - The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition) - . The image processing algorithms (Diamond view Plus) will be used for exposures without grid.

The SOMAVAC™ Device is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The single-patient use SOMAVAC™ Device is capable of generating sustained vacuum at the end two surgical drains to effectively remove bodily fluids after plastic or general surgeries. The SOMAVAC™ Device has a battery-powered SOMAVAC™ Pump assembly to generate vacuum with accessories, including disposable collection units, two drain connectors, and one belt. All products are non-sterile. Surgical drains are not included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distal inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains can be attached to the SOMAVAC™ Device. Each disposable waste collection units collects up to 100 mL of fluid. Versions of the device will be marketed with factory-set single, vacuum pressure levels ranging from 60 to 350mmHg. The device maintains suction throughout its use in a manner analogous to a thermostat by selectively running the pump motors to maintain the preset pressure. The device stops when the collection units are full or if the collection units are detached from the device. SOMAVAC™ Pump assembly has light and sound indicators to help users identify when the collection unit is full and ready to be exchanged, the battery is ready to be changed, or if there is a malfunction.

The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be inter hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

MAMMOMAT Revelation is a floor-mounted full field digital mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients. The system consists of an examination stand with X-ray generator, a gantry with tube housing assembly and mammography support table including detector, and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures. The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy.

The MAGNETOM systems [MAGNETOM Avantofit, MAGNETOM Skyrafit] are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

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