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Stephanix

FDA UDI

Class II (US FDA UDI)

by Stephanix

Identity

Trade Name
STEPHANIX FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. Not for mammography FDA UDI
Model / Reference
D2RS_AT FDA UDI
Description
The D2RS_AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. Not for mammography FDA UDI

Identifiers

Primary DI / UDI-DI
03664049000024 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

Yes

FDA UDI

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Stephanix by Stephanix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stephanix

Sources (1)

  • FDA UDI 0a71ffe0-a48c-4839-a94a-0cf684c8fe8f 34 fields · synced May 30, 2026