Owandy-RX DC

FDA UDI

Class II (US FDA UDI)

by Owandy Radiology

Identity

Trade Name: Owandy-RX DC FDA UDI
Generic Name: Mobile intraoral dental x-ray system, digital FDA UDI
Device Name: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device. FDA UDI
Model / Reference: DC OWANDY 115V VET,SHORT CONE,MOBILE FDA UDI
Description: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device. FDA UDI

Identifiers

Catalog Number: 5.92.15609 FDA UDI
Primary DI / UDI-DI: 03760262653075 FDA UDI
510(k) Number: K231055 FDA UDI
FDA Product Code: EHD FDA UDI
GMDN Term: Mobile intraoral dental x-ray system, digital 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

FDA UDI

Category: Mobile intraoral dental x-ray system, digital

Owandy-RX DC by Owandy Radiology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K231055 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: Owandy Radiology

Sources (1)

FDA UDI 79e10fec-fee2-4122-bce2-90a03406e953 36 fields · synced May 31, 2026