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510(k) Data Aggregation
K Number
K140723Device Name
NOMAD MD 75K V HANDHELD X-RAY SYSTEM
Manufacturer
ARIBEX, INC.
Date Cleared
2014-08-19
(151 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
ARIBEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities.
It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
Device Description
The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply.
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K Number
K081664Device Name
NOMAD PRO X-RAY SYSTEM
Manufacturer
ARIBEX, INC.
Date Cleared
2008-06-23
(10 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ARIBEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOMAD Pro X-ray System is intended to be used by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray images using intraoral image receptors.
Device Description
NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
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K Number
K051795Device Name
NOMAD DENTAL X-RAY SYSTEM
Manufacturer
ARIBEX, INC.
Date Cleared
2005-07-14
(9 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ARIBEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOMAD™ DENTAL X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.
Device Description
NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.
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