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510(k) Data Aggregation

    K Number
    K250587
    Device Name
    Orthoscan TAU Mini C-Arm
    Manufacturer
    Ziehm-Orthoscan, Inc.
    Date Cleared
    2025-07-02

    (125 days)

    Product Code
    OXO, JAA, MQB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243452
    Device Name
    Orthoscan VERSA Mini C-Arm
    Manufacturer
    Ziehm-Orthoscan, Inc.
    Date Cleared
    2025-01-14

    (68 days)

    Product Code
    OXO, JAA, MQB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgency, traumatology, orthopedic, critical care, or physician office environments.
    Device Description
    The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan VERSA, for distinction from predicate Orthoscan TAU and Orthoscan Mobile DI) retain identical function as the predicate TAU Mini C-arm (K2131130) and predicate Mobile DI (K113708) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees. The system consists of C-arm support attached to the image workstation. The changes to the Orthoscan VERSA Mini C-arm X-ray system represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-arm (K113708). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04 and related software revisions, modification to the mechanical design to further facilitate desk top use, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead and an update to wireless footswitch communication protocol.
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    K Number
    K240828
    Device Name
    OEC One ASD
    Manufacturer
    GE Hualun Medical Systems Co. Ltd.
    Date Cleared
    2024-12-27

    (276 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
    Device Description
    The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end. The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The subject device is labelled as OEC One ASD.
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    K Number
    K233669
    Device Name
    OEC 3D
    Manufacturer
    GE OEC Medical Systems, Inc.
    Date Cleared
    2024-03-28

    (134 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal.endoscopic, urologic, neurologic, vascular, cardiac, critical care, and emergency procedures.
    Device Description
    The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-ray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two major components, a C-Arm and a tethered Workstation. The C-Arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral) that allow the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector. Its functionality is controlled by software on the Workstation and on the OEC Touch, a digital flat panel controller mounted on the cross-arm. The workstation is a stable mobile platform with an articulating arm supporting a color image high resolution LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems. The Workstation is the primary user interface to the system and can be located at a convenient location in the room independent of where the C-Arm is located.
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    K Number
    K213113
    Device Name
    Orthoscan Tau Mini C-Arm
    Manufacturer
    Orthoscan, Inc.
    Date Cleared
    2021-10-21

    (24 days)

    Product Code
    OXO, JAA, MQB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthoscan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including when imaging limbs/extremities, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
    Device Description
    The proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders, knees, and Hips. The system consists of C-arm support attached to the image workstation. The changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.
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    K Number
    K203346
    Device Name
    OEC 3D
    Manufacturer
    GE OEC Medical Systems, Inc.
    Date Cleared
    2021-03-05

    (112 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediativ populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, neurologic, vascular, cardiac, citical care and emergency procedures.
    Device Description
    The OEC 3D is a mobile fluoroscopic C-arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-ray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two primary physical components. The first is referred to as the "C -Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", and this is the primary user interface for the user to interact with the system. The C-arm has an interface tablet allowing a technician to interact with the system. The C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral) that allow the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector, The workstation is a stable mobile platform with an articulating arm supporting a color image high resolution LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems. On the C-Arm, the generator remains unchanged from the OEC Elite. This is also true for the 31 cm x 31 cm image receptor, consisting of a Thallium-doped Cesium Iodide [Cs] (TI)] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager. The X-ray tube housing and insert remains the same as on the predicate OEC Elite (K192819). C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm base. Motion is controlled by a joystick. On the workstation, the main hardware includes a computer with integrated wireless capability and a dedicated computer for 3D reconstruction located within the storage bay. The OEC 3D employs the same software architecture and platform design that fully supports the flat panel detector as the OEC Elite and complies with IEC 60601-1. The OEC 3D includes the existing 2D imaging functionalities available on the OEC Elite including imaging and post processing applications.
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    K Number
    K192819
    Device Name
    OEC Elite
    Manufacturer
    GE OEC Medical Systems, Inc.
    Date Cleared
    2019-11-08

    (38 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, cardiac, critical care, and emergency procedures.
    Device Description
    The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-Ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C - arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The C-Arm is comprised of the high voltage generator, software. X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired. The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems. GE is submitting this pre-market notification for proposed labeling changes (quantitative performance claims) related to a previously-released feature, Enhanced Noise Reduction.
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    K Number
    K190024
    Device Name
    Smart-C
    Manufacturer
    Turner Imaging Systems, Inc.
    Date Cleared
    2019-09-27

    (263 days)

    Product Code
    OXO, JAA
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smart-C is a mini C-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
    Device Description
    The Smart-C is an ultra-portable, battery-powered, mobile fluoroscopic mini C-arm system. The main component is a mini C-arm that consists of a CMOS flat panel detector aligned with an X-ray source monoblock to be used for image acquisition. The system can be hand-transported for imaging at the point of care. The primary operator workstation is a tablet computer that receives the images from the C-arm via wireless transfer protocol. The system includes a wireless footswitch to initiate image acquisition, making the entire system cord-free during operation. It comes with 2 battery packs, a table-top battery charger, and a tablet docking station. An optional Monitor Cart is provided as an accessory. The Smart-C monitor cart includes a 27" full-color touchscreen monitor, a keyboard for data entry, a printer for hard-copy of the x-ray images, and a battery charger for the Smart-C battery packs. The whole cart is battery-powered, to provide a completely cord-free user experience.
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    K Number
    K183220
    Device Name
    OrthoScan TAU Mini C-Arm
    Manufacturer
    Orthoscan, Inc.
    Date Cleared
    2019-06-21

    (213 days)

    Product Code
    OXO, JAA, MQB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoScan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatic populations when imaging limbs/extremittes, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
    Device Description
    The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders, knees, and Hips. The system consists of C-arm support attached to the image workstation. The proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition. The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and rotational movements at various angles and distances when imaging the patient's anatomical structures. The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging. The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.
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    K Number
    K182626
    Device Name
    OEC One
    Manufacturer
    GE Hualun Medical Systems Co., Ltd.
    Date Cleared
    2018-11-16

    (53 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Product Code :

    OXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
    Device Description
    The OEC One™ is a mobile C-arm x-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, vascular, neurologic, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has an image intensifier on the top of the C-arm and the X-ray Source assembly at the opposite end. The OEC One™ is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The subject device is labelled as OEC One.
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