FDA.reportPublic FDA data

Packaged System, Kavo Nomad Pro2, US

Primary DI
EKAV101320400
Brand
Packaged System, Kavo Nomad Pro2, US
Company
ARIBEX, INC.
Model
1.013.2040
Catalog number
1.013.2040
Device description
This is a medical device.
Published
2020-02-21
Public version status
New
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
K173319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173319000KaVo NOMAD Pro 2 Handheld X-ray SystemAribex2017-11-16EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101320400PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18882755286nomadsupport@kavo.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
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
EKAV085000040NOMAD™ handheld X-ray system0.850.0004FP 0002 RFB2016-09-24
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