Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K250282
    Device Name
    Persona C HR
    Manufacturer
    A.T.S. Applicazione Tecnologie Speciali s.r.l.
    Date Cleared
    2025-04-30

    (89 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.T.S. Applicazione Tecnologie Speciali s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device. Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.
    Device Description
    PERSONA C HR is a C-arm mobile unit with flat panel detector. It allows imaging under the following modes: - Low Dose Fluoroscopy, - High Quality Fluoroscopy, - High Quality + Fluoroscopy - Digital radiography (Snapshot), - Fluoroscopy in Road Mapping mode (optional), - Fluoroscopy in DSA mode (optional). It is provided with a 30x30 cm Flat Panel detector and a 25 kW X-ray generator. The unit is composed of: Monitor unit, Stand with c-arm, X-ray commands, Printer (optional). The device acquires images employing X-rays emitted by an X-ray source which can produce up to 25kW. The unit, which is powered by a single-phase electrical supply, generates ionizing radiations (X-rays) which, as they pass through the patient, reach a flat panel detector that produces radiological images. An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation. The images collected by the detector are sent to a video processor, which, after processing the information received, allows radiological images to be displayed on the display monitor.
    Ask a Question
    K Number
    K211777
    Device Name
    ARCO FP-S
    Manufacturer
    A.T.S. Applicazione Tecnologie Speciali S.R.L.
    Date Cleared
    2021-08-13

    (65 days)

    Product Code
    OWB, IZI, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.T.S. Applicazione Tecnologie Speciali S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.
    Device Description
    ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel". It will be realized in 2 models, depending on the size of the detector: Model: ARCO FP-SR21 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel. Models: ARCO FP-SR30 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel. The system consists of: C-arm Stand, X-RAY MONOBLOC, rotating anode, FLAT PANEL DETECTORS: 2121cm or 3030cm, MONITOR LCD 27" QUAD HD format 16:9, CONTROL PANEL, X-RAY COLLIMATOR, SYSTEM CONTROLLER, X-RAY HAND SWITCH, ARTICULATED ARM FOR MONITOR SUPPORT, ANTISCATTERING GRID. Optional components include FOOTSWITCH, two-foot pedal, LASER LOCALISER, Dose Area Meter, DSA Packages, I.R. remote controls, DICOM Classes, EXTERNAL VIDEO OUTPUT-Wireless transmission, DICOM DATA Wi-Fi transmission to Ethernet/PACS, NFC LOGIN, Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.
    Ask a Question
    K Number
    K211542
    Device Name
    PRIMO S
    Manufacturer
    A.T.S. Applicazione Tecnologie Speciali S.R.L.
    Date Cleared
    2021-07-09

    (51 days)

    Product Code
    MQB, IZL
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.T.S. Applicazione Tecnologie Speciali S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
    Device Description
    PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems: - mobile units - fixed installations. The PRIMO S VP application provides the following functions: - User login: the device is usable only by authenticated users - Management of the operator interface GUIs and setup of the application itself - The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.) - Management of patient data through manual entry and reception from the DICOM WORKLIST service - Management of image processing algorithms for each type of examination - Management of the automatic advancement procedures of the operations during the study. - Image acquisition and processing - Saving in Hard Disk of the acquired images - Automatic and manual image stitching procedure - Off-line image editing and optimization using process and graphic functions - Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, MPPS, RDSR, STORAGE COMMITMENT - Application configuration setup - Export and automatic saving of images on external support (USB key) The application communicates with the Sedecal equipment through software modules (DLL) for: - The choice of the examination, made by the operator through a GUI defined by Sedecal (APR) - Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...) - Receive the system status parameters and the exposure result
    Ask a Question
    K Number
    K182086
    Device Name
    ARCO FP
    Manufacturer
    A.T.S. Applicazione Tecnologie Speciali s.r.l.
    Date Cleared
    2019-08-20

    (383 days)

    Product Code
    OWB, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.T.S. Applicazione Tecnologie Speciali s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARCO FP is a mobile x-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. Arco FP device can be used on all patients except pediatric patients within the limits of the device.
    Device Description
    ARCO FP is a mobile x-ray device.
    Ask a Question

    Page 1 of 1