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510(k) Data Aggregation
K Number
K041137Device Name
NEWTOM 3G QR-DVT 9000
Manufacturer
APERIO SERVICES, LLC
Date Cleared
2004-05-14
(14 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
APERIO SERVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NewTom QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient chaghestion and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
Device Description
The NewTom 3G is a dedicated X-Ray imaging device that uses an X-Ray imaging system and a patient table. The NewTom 3G acquires a 360-degree rotational X-Ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images. The NewTom 3G can measure distances and thickness on two-dimensional images.
Images produced by the NewTom 3G can be printed or exported on magnetic and optical media.
The NewTom 3G is designed for use in diagnostic support both in odontoiatric radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.
The Newlom 3G hardware, including a patient table and a gantry (comprised of an X-ray Source, image chain and a motorized arm) facilitates the acquisition of a full X-Ray sequence by the device's software. The NewTom software runs either in a Windows 2K or Windows XP workstation.
The NewTom 3G is an X-Ray imaging device that constructs a three-dimensional model from images taken during a rotational X-Ray sequence. The NewTom 3G is optimized for bone morphology analysis on the maxillofacial region.
The NewTom 3G reconstructs a three-dimensional model for X-Ray images similar to the three-dimensional model obtained using the original NewTom X-Ray system.
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K Number
K003787Device Name
NEWTOM QR-DVT 9000
Manufacturer
APERIO SERVICES, LLC
Date Cleared
2001-03-08
(90 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
APERIO SERVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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