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510(k) Data Aggregation
K Number
K210151Device Name
Digimamo D
Manufacturer
VMI Tecnologias LTDA
Date Cleared
2022-03-01
(404 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
VMI Tecnologias LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digimamo D ® Full-Field Digital Mammography System is a device intended to produce planar digital x-ay images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems.
Device Description
This is a mammography system available in only a digital version. The main characteristics are: Operation Panel/Console, X-ray tube information, Filter Selection, Window Material and thickness, Focal Spot Sizes, Operating principle, Radiological Characteristics, Column and Gantry, Flat Panel Detector, Workstation.
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K Number
K202388Device Name
Apolo D / Apolo S
Manufacturer
VMI Tecnologias LTDA
Date Cleared
2020-12-01
(102 days)
Product Code
KPR, MOB, MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
VMI Tecnologias LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Device Description
This is a multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation for image acquisition, processing and visualization. The equipment was developed to perform radiographic examinations of patients in reclining, standing or sitting positions. Six possible tube head configurations are available: FLOOR TO CELLING TUBE STAND, FLOOR MOUNTED TUBE STAND, ROTARY U-ARM mount with integrated film/digital cassette mount, MANUAL CEILING-MOUNTED TELESCOPIC TUBE STAND, MOTORIZED CEILING-MOUNTED TELESCOPIC TUBE STAND, ROTARY STRAIGHT ARM mount with integrated film/digital cassette mount. The Apolo provides a complete x-ray system with generator, tube head, and collimator. The generator is made by us, VMI, whereas the tube head, collimator, and digital x-ray receptor panels/software are made by other manufacturers. Tube heads are typically Toshiba and collimators are typically Ralco. The Apolo D comes with digital x-ray receptor panels (see the comparison table below) while the Apolo S comes without digital x-ray receptor panels. This system employs without modification software Econsole cleared in K152172. This software has a Moderate level of concern. The reference detectors made by DRTECH can be used with anti-scatter grids.
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K Number
K201340Device Name
AQUILA 320 D / AQUILA 320 S
Manufacturer
VMI Tecnologias LTDA
Date Cleared
2020-06-19
(30 days)
Product Code
IZL, MQB
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
VMI Tecnologias LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Device Description
Aquila 320-D Series: Small, light, easy handling. High Performance, High Power 320 mA, Leading Technology. Capacitive discharge technology, wireless image capture and transmission technology, smartphone image access. Wireless Detector and Workstation on touchscreen notebook or tablet. High frequency generator with micro-processor controls: Power 35.2 KW (The Aquila 320-S comes without the digital panels and workstation)
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