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510(k) Data Aggregation
K Number
K151612Device Name
NewTom VGi evo
Manufacturer
QR S.r.l.
Date Cleared
2016-03-31
(290 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
QR S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NewTom VGi evo is a cone beam computed tomographic x-ray imaging system that acquires of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views (tomographic sections, pan and ceph projections) displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Device Description
The medical electrical equipment NewTom VGi evo is an X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display. It is manufactured by QR s.r.l. and the applicable product code is OAS, Regulation 21CFR 892.1750 Computed tomography x-ray system, Class II.
NewTom VGi evo acquires a sequence of X-ray images rotating around the patient's head and then uses these images to reconstruct a three-dimensional matrix of the volume examined and produce two-dimensional views of this volume. These views can be used to reconstruct additional two-dimensional images, on which distances and angles can be measured, and threedimensional images. Each image produced can then by printed or exported onto optical media. The NewTom VGi evo hardware system is composed of the scanner unit, the control box and the external workstation, which enables the user to acquire data easily with the aid of the specific software. The software requires Windows 7 64bit operating system.
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K Number
K142222Device Name
NewTom 5G
Manufacturer
QR S.r.l.
Date Cleared
2015-01-26
(166 days)
Product Code
JAK, OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
QR S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.
Device Description
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.
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K Number
K130442Device Name
NEWTOM VGI AND NEWTOM 5G
Manufacturer
QR S.R.L.
Date Cleared
2013-07-03
(132 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
QR S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 derree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
NewTom 5G is especially designed for:
- dento-maxillo-facial complex imaging;
- teeth, mandible and jaw imaging for implant planning;
- temporal-mandibular joint (TMJ) imaging;
- ear, nose and throat (ENT) analysis;
- sections of upper cervical-spine imaging;
Device Description
NewTom VGi and NewTom 5G are cone beam computed tomography x-ray imaging systems that acquire a 360 degree rotational sequences of the head. The devices reconstruct a three dimensional matrix of the examined volume and produce two dimensional views of this volume, displaying both two and three dimensional images.
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K Number
K110260Device Name
NEWTOM 5G / NEWTOM 5G VERSION FP
Manufacturer
QR S.R.L.
Date Cleared
2011-04-06
(68 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
QR S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NewTom 5G Computed Tomography X-Ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
The NewTom 5G accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.
Device Description
The NewTom 5G is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom 5G can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.
The NewTom 5G hardware, including a scanner unit (comprised of the X-ray source, flat panel detector and the motorized arm) and a motorized patient support, facilitates the acquisition of a full X-ray sequence by the device software. The NewTom 5G software runs on an x86 architecture based workstation. The NewTom 5G reconstructs a three-dimensional model of X-ray images similar to the three-dimensional model obtained using the parent NewTom VG Computed Tomography X-Ray System.
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