FDA.reportPublic FDA data

NOMAD MD™ handheld X-ray system

Primary DI
EKAV085000300
Brand
NOMAD MD™ handheld X-ray system
Company
ARIBEX, INC.
Model
0.850.0030
Catalog number
FP 0201
Device description
Handheld X-ray
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
IZLSystem, x-ray, mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140723000NOMAD MD 75K V HANDHELD X-RAY SYSTEMAribex, Inc.2014-08-19IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV085000300PrimaryHIBCC0

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
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
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

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Primary DI, Brand, Company table
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