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The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

The Atellica IM Thyroglobulin (Tg) assay includes: - **Tg ReadyPack primary reagent pack:** - **Lite Reagent:** mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives (7.5 mL/reagent pack). - **Solid Phase:** streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives (15.0 mL/reagent pack). - **Ancillary Well Reagent:** BSA; bovine gamma globulin; buffer; preservatives (6.0 mL/reagent pack). - **Tg CAL:** After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives (2.0 mL/vial). The following devices are sold separately: - **Atellica IM Tg MCM:** - **MCM 1:** After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives (1.0 mL/vial). - **MCM 2–5:** After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives (1.0 mL/vial).

The MAGNETOM system is 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 system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

The subject device, MAGNETOM Avanto Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Avanto Fit with syngo MR XA50A (K220151). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Avanto Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera BM Head/Neck 20 Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: myExam Autopilot Brain myExam Autopilot Knee 3D Whole Heart HASTE_interactive GRE_PC Open Recon Deep Resolve Gain Fleet Reference Scan Physio logging complex averaging AutoMate Cardiac Ghost Reduction BLADE diffusion Beat Sensor Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Skyra Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Skyra Fit with syngo MR XA50A (K220589). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Skyra Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: Beat Sensor HASTE_interactive GRE_PC 3D Whole Heart Deep Resolve Gain Open Recon Ghost Reduction Fleet Reference Scan BLADE diffusion HASTE diffusion Physio logging complex averaging Deep Resolve Swift Brain Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac SVS_EDIT Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Sola Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA51A (K221733). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Sola Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode The subject device, MAGNETOM Viato.Mobile with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Viato.Mobile with syngo MR XA51A (K240608). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Viato.Mobile with syngo MR XA70: Hardware New Hardware: n.a. Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode Furthermore, the following minor updates and changes were conducted for the subject devices: Low SAR Protocol minor update (for all subject devices but MAGNETOM Skyra Fit): the goal of the SAR adaptive protocols was to be able to perform knee, spine, heart and brain examinations with 50% of the max allowed SAR values in normal mode for head and whole-body SAR. The SAR reduction was achieved by parameter adaptations like Flip angle, TR, RF Pulse Type, Turbo Factor, concatenations. For cardiac clinically accepted alternative imaging contrasts are used (submitted with K232494). Implementation of image sorting prepare for PACS (submitted with K231560). Implementation of improved DICOM color support (submitted with K232494). Needle intervention AddIn was added all subject device (submitted with K232494). Inline Image Filter switchable for users: in the subject device, users have the ability to switch the "Inline image filter" (implicite Filter) on or off. This filter is an image-based filter that can be applied to specific pulse sequence types. The function of the filter remains unchanged from the previous device MAGNETOM Sola with syngo MR XA61A (K232535). SVS_EDIT is newly added for MAGNETOM Skyra Fit, but without any changes (submitted with K203443) Brain Assist received an improvement and is identical to that of snygo MR XA61A (K232535) Open Recon is introduced for all systems. The function of Open Recon remains unchanged from the previous submissions (submitted with K221733). Lock TR and FA in Bold received a minor UI update Implant Suite is newly introduced for MAGNETOM Sola Fit and MAGNETOM Viato.Mobile, but without any changes (submitted with K232535) myExam Autopilot Brain and myExam Autopilot Knee are newly introduced for the subject device MAGNETOM AVANTO Fit and are unchanged from previous submissions (submitted with K221733). myExam Angio Advanced Assist (Test Bolus) received a bug fixing and minimal UI improvements.

The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

The Dimension® LOCI® Thyroid Stimulating Hormone Flex® reagent cartridge (TSHL) and Dimension® LOCI® Free Thyroxine Flex® reagent cartridge (FT4L) assays were cleared under K081074 and K073604, respectively. The components of the cleared assays were modified to reduce biotin interference. The modified Assays are comprised of the following components: Dimension® LOCI® Thyroid Stimulating Hormone Flex® reagent cartridge (TSHL): prepackaged liquid reagents in a plastic eight-well cartridge. Wells 1-2 contain Biotinylated TSH antibody (7.5 µg/mL mouse monoclonal), wells 3-4 contain TSH antibody coated Chemibeads (200 µg/mL mouse monoclonal), and wells 5-6 contain Streptavidin Sensibeads (1400 µg/mL recombinant E. coli). Wells 1-6 contain buffers, stabilizers and preservatives. Wells 7-8 are empty. Dimension® LOCI® Free Thyroxine Flex® reagent cartridge (FT4L): prepackaged liquid reagents in a plastic eight-well cartridge. Wells 1-2 contain Streptavidin Sensibeads (225 µg/mL recombinant E. coli), wells 3-4 contain T3 Chemibeads (200 µg/mL), and wells 5-6 contain FT4 Biotinylated antibody (50 ng/mL mouse monoclonal). Wells 1-6 contain buffers, stabilizers and preservatives. Wells 7-8 are empty. Test Principle: Both devices use a homogeneous chemiluminescent immunoassay based on LOCI® technology. For TSHL, it's a sandwich immunoassay where sample is incubated with biotinylated antibody and Chemibeads to form bead-TSH-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads which diffuses into Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of TSH concentration. For FT4L, it's a sequential immunoassay where sample is incubated with biotinylated antibody. T3 Chemibeads are added and form bead/biotinylated antibody immunocomplexes with the non-saturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of FT4 concentration.

syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images. syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network. syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device. syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo Dynamics is a digital image display and reporting system with flexible deployment – it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types. The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy). syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations. syngo Dynamics provides various semi-automated anatomical visualization tools. syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices). In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

INNOVANCE Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency. INNOVANCE Antithrombin is indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

The INNOVANCE Antithrombin assay is suitable for the determination of physiologically active antithrombin on automatic analyzers and enables the diagnosis of inherited or acquired antithrombin deficiencies. The INNOVANCE Antithrombin assay utilizes a chromogenic measuring principle. An excess of human factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The substrate cleavage is determined by the increase in the absorbance value at 405 nm. The release of dye is inversely proportional to the inhibiting activity of antithrombin in the plasma sample, i.e., the smaller the concentration of functionally active antithrombin, the higher the absorbance signal per time unit.

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures using deep-learning-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT. The outputs of AI-Rad Companion Organs RT are intended to be used by trained medical professionals. The software is not intended to automatically detect or contour lesions.

AI-Rad Companion Organs RT provides automatic segmentation of pre-defined structures such as Organs-at-risk (OAR) from CT or MR medical series, prior to dosimetry planning in radiation therapy. AI-Rad Companion Organs RT is not intended to be used as a standalone diagnostic device and is not a clinical decision-making software. CT or MR series of images serve as input for AI-Rad Companion Organs RT and are acquired as part of a typical scanner acquisition. Once processed by the AI algorithms, generated contours in DICOMRTSTRUCT format are reviewed in a confirmation window, allowing clinical user to confirm or reject the contours before sending to the target system. Optionally, the user may select to directly transfer the contours to a configurable DICOM node (e.g., the Treatment Planning System (TPS), which is the standard location for the planning of radiation therapy). AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept the automatically generated contours. Then the output of AI-Rad Companion Organs RT must be reviewed and, where necessary, edited with appropriate software before accepting generated contours as input to treatment planning steps. The output of AI-Rad Companion Organs RT is intended to be used by qualified medical professionals, who can perform a complementary manual editing of the contours or add any new contours in the TPS (or any other interactive contouring application supporting DICOM-RT objects) as part of the routine clinical workflow.

Prostate MR AI is a plug-in Radiological Computer Assisted Detection and Diagnosis Software device intended to be used · with a separate hosting application · as a concurrent reading aid to assist radiologists in the interpretation of a prostate MRI examination acquired according to the PI-RADS standard · in adult men (40 years and older) with suspected cancer in treatment naïve prostate glands The plug-in software analyzes non-contrast T2 weighted (T2W) and diffusion weighted image (DWI) series to segment the prostate gland and to provide an automatic detection and segmentation of regions suspicious for cancer. For each suspicious region detected, the algorithm moreover provides a lesion Score, by way of PI-RADS interpretation suggestion. Outputs of the device should be interpreted consistently with ACR recommendations using all available MR data (e.g., dynamic contrast enhanced images [if available]). Patient management decisions should not be made solely based on analysis by the Prostate MR AI algorithm.

This premarket notification addresses the Siemens Healthineers Prostate MR AI (VA10A) Radiological Computer Assisted Detection and Diagnosis Software (CADe/CADx). Prostate MR AI is a Computer Assisted Detection and Diagnosis algorithm designed to plug into a hosting workflow that assists radiologists in the detection of suspicious lesions and their classification. It is used as a concurrent reading aid to assist radiologists in the interpretation of a prostate MRI examination acquired according to the PI-RADS standard. The automatic lesion detection requires transversal T2W and DWI series as inputs. The device automatically exports a list of detected prostate regions that are suspicious for cancer (each list entry consists of contours and a classification by Score and Level of Suspicion (LoS)), a computed suspicion map, and a per-case LoS. The results of the Prostate MR AI plug-in (with the case-level LoS, lesion center points, lesion diameters, lesion ADC median, lesion 10th percentile, suspicion map, and non-PZ segmentation considered optional) are to be shown in a hosting application that allows the radiologist to view the original case, as well as confirm, reject, or edit lesion candidates with their contours and Scores as generated by the Prostate MR AI plug-in. Moreover, the radiologist can add lesions with contours and PI-RADS scores and finalize the case. In addition, the outputs include an automatically computed prostate segmentation, as well as sub-segmentations of the peripheral zone and the rest of the prostate (non-PZ). The algorithm will augment the prostate workflow of currently cleared syngo.MR General Engine if activated via a separate license on the General Engine.

The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

The Atellica CH Crea3 assay is based on the reaction of picrate with creatinine in an alkaline medium to produce a red chromophore creatinine picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration. The Atellica CH Crea3 assay is a modification of the Jaffe method, using rate blanking and intercept correction. Rate blanking is used to minimize bilirubin interference. Also, because non-specific serum/plasma protein interactions with this reagent have been found to produce a positive bias of approximately 0.3 mg/dL (26.5 µmol/L), serum/plasma measurements are automatically corrected by subtracting 0.3 mg/dL (26.5 µmol/L) from each result.

INNOVANCE Anti-Xa assay in combination with INNOVANCE Heparin Calibrator is an In-vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of UFH and LMWH can be performed on the BCS XP System, CS-2500 System, CS-5100 System and the CA-660 System. For use with plasma from patients undergoing anticoagulant therapy with either UFH or LMWH. INNOVANCE Anti-Xa assay in combination with INNOVANCE Apixaban Standard provides quantitative determination of the concentration of apixaban in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of apixaban can be performed on CS-2500 System. For use with plasma from patients undergoing anticoagulant therapy with apixaban in situations where quantification of apixaban levels may be indicated: · Patient with bleeding, · Patient with risk for bleeding (e.g. during perioperative management), · Patient with conditions affecting pharmacokinetics (e.g. deteriorating renal function, extremes of body weight, treatment with other drugs known to affect pharmacokinetics of apixaban). The performance of this device has not been established in neonate and pediatric patient populations.

INNOVANCE Anti-Xa assay is a one stage chromogenic assay. The reagent kit consists of two components. One component (Reagent) contains Xa. the other (Substrate) a chromogenic substrate specific for Xa. Upon mixing of INNOVANCE Anti-Xa Reagent and INNOVANCE Anti-Xa Substrate, Xa converts the chromogenic substrate into two products, one of them is paranitroaniline. The formation of paranitroaniline can be quantified by the coaqulation analyzer employing light absorption at a specific wavelength (405 nm). In the presence of a heparin containing sample the formation of paranitroaniline will be reduced in a time dependent manner. This is due to inhibition of Xa by the heparin/AT complex is formed in the patient's plasma and competes with the substrate conversion by Xa. The concentration of the complex is not only dependent on the concentration of heparin but also on the availability of the patient's endogenous antithrombin. By comparison to a reference curve the heparin activity of the sample can be quantified. To reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture. In the presence of an apixaban containing sample factor Xa is inhibited directly by this inhibitor. Comparison to an inhibitor specific reference curve allows quantification of the inhibitor concentration in the sample.

MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.

myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation. The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility. The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT. The application includes means and functionalities to support in: · Multimodality viewing and contouring of anatomical, and multi-parametric images such as CT, CBCT, PET/CT, MRI · Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique - Manual and semi-automatic registration using rigid and deformable registration - · Expansion of created contour structures to visualize a safety margin · Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data - · Export of virtual needle paths in the Dicom SSO format - · Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities - Supports multimodality image fusion - · Supports user's procedure flow via a task stepper Thermal ablation cannot be triggered from myAblation Guide.