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510(k) Data Aggregation
K Number
K200944Device Name
UNIEXPERT 2 PLUS
Manufacturer
Adani
Date Cleared
2020-05-26
(48 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Adani
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIEXPERT 2 PLUS is a stationary general-purpose radiographic imaging system indicated for use in acquiring diagnostic X-Ray images of osseous structures and soft tissues of the human body to aid physicians with patient diagnosis. The system has analogue, computed radiography (CR) as well as digital radiography (DR) imaging capabilities. The UNIEXPERT 2 PLUS is not indicated for use in mammography.
Device Description
The UNIEXPERT 2 PLUS is a diagnostic X-Ray system intended for radiographic imaging of osseous structures and soft tissues of the human body. The system may be used for analogue film imaging as well as digital image acquisition.
The UNIEXPERT 2 PLUS is comprised of an X-Ray generator with user interface, X-Ray tube, beam limiting device, vertical column tube stand, radiographic table, vertical wall stand, digital X-Ray image detector.
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K Number
K172027Device Name
Adani MammoScan
Manufacturer
ADANI
Date Cleared
2017-10-20
(107 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
ADANI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ray images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.
Device Description
The Adani MammoScan is a full-field type digital mammography system comprised of an image acquisition system, a gantry and an acquisition station, equipped with PC computer, keyboard, mouse, monitor and a protective shield. The image acquisition system includes a built-in digital detector of CCD-TDI technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression mechanism, and slit collimator. The slit-collimator shapes the beam and limits the x-ray beam to the active width of the detector, which prevents image degradation caused by scattered radiation. During image acquisition, the internal swing arm is motor driven to pivot at the x-ray tube with the slit collimator, causing the detector (at the other end of the swing arm and on the far side of the breast support) to swing in an arc under the breast support from one edge of the breast support to the other. The x-ray, which is shaped into a flat fan-shaped beam by the slit collimator, passes through the compressed breast tissue as it sweeps across the breast support and falls on the image detector underneath. The acquisition workstation is the user interface for preparing and initiating image acquisition, image pre- and post-processing, and image transfer to the desired destination (e.g. PACS) for interpretation and archiving. The MammoScan® Full-Field Digital Mammography System consists of a high-voltage generator, gantry, an acquisition work station with a technologist shield and accessories. The patient is imaged at the gantry contains the diagnostic source (x-ray tube, filter, and collimator), built-in solid state image detector, breast support, and compression assembly. The gantry can be raised, lowered, and rotated, under motorized control, to accommodate patients of all statures, standing and/or sitting, to produce images in all standard views.
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