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The syngo.CT Lung CAD VC30 device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.

Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules ≥ 3.0 mm in size. The device processes images acquired with Siemens multi-detector CT scanners with 4 or more detector rows. The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular). The detection performance of the syngo.CT Lung CAD device is optimized for nodules between 3.0 mm and 20.0 mm in size. The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images for use in a second reader mode. syngo MM Oncology (FDA clearance k191309) is implemented on the syngo.via platform (FDA clearance k191040), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device is intended to be used as a second reader only after the initial read is completed. The subject device and the predicate device has the same basic technical characteristics as the predicate; however, the fundamental technology has been replaced by deep learning technology. Specifically, the predicate VC20 uses feature-based and Machine Learning whereas the current VC30 uses algorithms based on Convolutional Neural Networks. This does not introduce new types of safety or effectiveness concerns. In particular, as demonstrated by the statistical analysis and results of the standalone benchmark evaluations: i. The standalone accuracy has been shown not only to be non-inferior but actually superior to that of the device and ii. The marks generated by the two devices have been shown to be reasonably consistent. This device description holds true for the subject device, syngo.CT Lung CAD, software version VC30, as well as the predicate device, syngo.CT Lung CAD, software version VC20.

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.

Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos Agile Max is not for mammography examinations. Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos dRF Max is not for mammography examinations. Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients Multitom Rax is not for mammography examinations. Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract. The table supports endourological and minimal invasive surgery in urology as there are transurethral interventions (e.g. ureterorenoscopy (URS), double stent placement, cystoscopy. transurethral resection of bladder tumors (TURB), transurethral resection of the prostate (TURP)), percutaneous urological procedures (e.g. percutaneous nephrostomy (PCN), percutaneous nephrolitholapaxy (PCNL)), urological X-ray diagnosis (e.g. survey imaging of the kidney, ureter, and bladder (KUB), intravenous pyelogram (IVP), retrograde pyelography), micturition cystourethrogram (MCU), videourodynamics, laparoscopic procedures and minor open urological interventions. The system may be used on pediatric, adult and bariatric patients. Uroskop Omnia Max is not for mammography examinations.

All four radiology imaging devices are stationary X-ray systems for radiography and fluoroscopy. They use the same X-ray generator, the same X-ray tube and similar collimators. They also share the same imaging and system control device: The Fluorospot Compact. The reason for this submission is the upgrade of all systems to the software VF10. This new software will bring the following new features to the devices: IEC 4th for EMC, Windows 10, Cybersecurity package, Pediatric package, Use hospital IT (e.g. RIS) on modality, 16 fps mode for 3D (Multitom Rax only), SSXI update. The image processing algorithms (Diamond View Plus) will be used for exposures without grid and fluoroscopy image processing algorithms will be enhanced and called "Clearview". Also the name suffix "Max" is being established as an addition to the product name of Luminos Agile, Luminos dRF and Uroskop Omnia.

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.

Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.

The Siemens volumetric breast density analysis application software Insight BD provides volumetric assessment of digital x-ray images of the breast, including both digital mammograms and raw tomosynthesis projection images. The assessment consists of generating and evaluating density maps where the value at each pixel represents the thickness of fibroglandular tissue above that pixel. From those density maps the software calculates quantitative values, namely - . volume of fibroglandular tissue in the breast in cm³ - breast volume in cm³ . - . volumetric breast density in % - . breast density grade The breast density grade is computed by thresholding of the volumetric breast density and conforms to BI-RADS® 5th Edition breast composition categories. The masking effect of dense fibroglandular tissue is automatically included in the results. Insight BD is a software option for the Siemens digital mammography systems. Insight BD may be installed either on Siemens released PC hardware or on the Siemens digital mammography systems. Breast Density results are stored in the DICOM header and can be used for further documentation.

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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The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.