NOMAD™ handheld X-ray system

FDA UDI

Class II (US FDA UDI)

by Aribex, Inc.

Identity

Trade Name: NOMAD™ handheld X-ray system FDA UDI
Generic Name: Diagnostic x-ray system generator, hand-held FDA UDI
Device Name: Handheld X-ray FDA UDI
Model / Reference: 0.850.0001 FDA UDI
Description: Handheld X-ray FDA UDI

Identifiers

Catalog Number: FP 0001 HSC FDA UDI
Primary DI / UDI-DI: EKAV085000010 FDA UDI
510(k) Number: K051795 FDA UDI
FDA Product Code: EHD FDA UDI
GMDN Term: Diagnostic x-ray system generator, hand-held FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray system generator, hand-held

NOMAD™ handheld X-ray system by Aribex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray system generator, hand-held.

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DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
NOMAD Pro 2 — Dental Imaging Technologies Corporation · Class II
NOMAD Pro2 Packaged X-Ray System Black-R — Dental Imaging Technologies Corporation · Class II
woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II

Cleared under the same submission

K051795 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Aribex, Inc.

Sources (1)

FDA UDI ba31a615-8e54-4b3f-a479-2686dfb60b73 37 fields · synced May 30, 2026