(61 days)
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No
The description focuses on mechanical positioning and interlock systems, with no mention of AI/ML terms or functions related to image analysis, decision support, or automated control beyond basic safety interlocks.
No
The device is described as supporting and positioning X-ray components for diagnostic fluoroscopic procedures. It does not actively treat or diagnose a disease or condition itself.
No
The device is a positioner for an X-ray tube and image intensifier, which are used in diagnostic fluoroscopic procedures. The device itself does not perform diagnosis; it facilitates the imaging process by holding and positioning the imaging components.
No
The device description clearly describes a physical, ceiling-mounted C-arm positioner with mechanical and electrical components (motorized movement, microswitch, detent, rails). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The B-350 Ceiling Mounted C-Positioner is a mechanical device designed to physically hold and position an X-ray tube and image intensifier for fluoroscopic procedures. It facilitates the creation of medical images within the body, not the analysis of samples taken from the body.
- Intended Use: The intended use clearly states "To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures." This describes a device that aids in the imaging process itself, not the analysis of biological samples.
Therefore, the B-350 Ceiling Mounted C-Positioner falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.
Product codes
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Device Description
The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.
The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Fisher's PEGASUS Ceiling Mounted Cardiac Positioner, Philips DIAGNOST Lateral C-Arm, Fisher's ARIEL Ceiling Mounted C-Arm, and Fisher's CPS Ceiling Mounted Imaging System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
MAY | 4 1997
510(k) Summarv
March 25, 1997
Submitter: Omega Medical Imaging, Inc. 675 Hickman Circle, Sanford, FL 32771. Douglas Coon, President.
Device Name: B-350 Isocentric Ceiling Mounted C-Positioner.
Classification Name: System, Fluoroscopic, Image Intensified, All Types.
Common/Usual Name: C-Arm
Substantially Equivalent Devices: Fisher's PEGASUS Ceiling Mounted Cardiac Positioner, Philips DIAGNOST Lateral C-Arm, Fisher's ARIEL Ceiling Mounted C-Arm, and Fisher's CPS Ceiling Mounted Imaging System.
Description: The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.
The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.
Intended Use: To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.
Summary of Technological Characteristics: The B-350 Ceiling Mounted C-Positioner has the same technological characteristics as the predicate devices. The B-350 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures. The only differences in the devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations depending on user preference. The Omega B-350 Ceiling Mounted C-Positioner (C-Arm) is substantially equivalent to the predicate devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years.