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Owandy-RX DC

FDA UDI

Class II (US FDA UDI)

by Owandy Radiology

Identity

Trade Name
Owandy-RX DC FDA UDI
Generic Name
Stationary 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,BOTT 40 (16” - 40,64cm) 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
5.92.15606 FDA UDI
Primary DI / UDI-DI
03760262653044 FDA UDI
510(k) Number
K231055 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary intraoral dental x-ray system, digital

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

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

Cleared under the same submission

K231055 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owandy Radiology

Sources (1)

  • FDA UDI 9814227d-cc27-4af4-bc1f-1d0dee20cce4 36 fields · synced May 30, 2026