FDA.reportPublic FDA data

NOMAD™ handheld X-ray system

Primary DI
EKAV085000040
Brand
NOMAD™ handheld X-ray system
Company
ARIBEX, INC.
Model
0.850.0004
Catalog number
FP 0002 RFB
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHDUNIT, X-RAY, EXTRAORAL WITH TIMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051795000NOMAD DENTAL X-RAY SYSTEMAribex, Inc.2005-07-14EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV085000040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, hand-heldAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18663405522support@aribex.com

Regulatory Flags#

DUNS number
169065526
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV101320400Packaged System, Kavo Nomad Pro2, US1.013.20401.013.20402020-02-21
EKAV101320410Packaged System, Kavo Nomad Pro2, GBL1.013.20411.013.20412020-02-21
EKAV101377890Packaged System, KaVo Nomad Pro2, CA1.013.77891.013.77892020-02-21
EKAV085000000NOMAD™ handheld X-ray system0.850.0000FP 00012016-09-24
EKAV085000010NOMAD™ handheld X-ray system0.850.0001FP 0001 HSC2016-09-24
EKAV085000020NOMAD™ handheld X-ray system0.850.0002FP 00022016-09-24
EKAV085000030NOMAD™ handheld X-ray system0.850.0003FP 0002 HSC2016-09-24
EKAV085000150NOMAD™ handheld X-ray system0.850.0015FP 00122016-09-24
EKAV085000210NOMAD Pro 2™0.850.0021FP 01502016-09-24
EKAV085000220NOMAD Pro 2™0.850.0022FP 01512016-09-24
EKAV085000250NOMAD Pro 2™0.850.0025FP 01902016-09-24
EKAV085000260NOMAD Pro 2™0.850.0026FP 0190 HSC2016-09-24
EKAV085000280NOMAD Pro 2™0.850.0028FP 01922016-09-24
EKAV085000300NOMAD MD™ handheld X-ray system0.850.0030FP 02012016-09-24
EKAV085000420NOMAD™ handheld X-ray system0.850.0042AP 0001 RFB2016-09-24
EKAV085001120NOMAD MD™ handheld X-ray system0.850.0112AP 02002016-09-24
EKAV085004700NOMAD MD™ handheld X-ray system0.850.0470FP 02042016-09-24
EKAV085004710NOMAD MD™ handheld X-ray system0.850.0471FP 02022016-09-24
EKAV101152780NOMAD MD™ handheld X-ray system1.011.5278FP 02032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10