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OEC One CFD

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 7999000PCMModel OEC One CFD

by GE HUALUN MEDICAL SYSTEMS CO. Ltd

Identity

Trade Name
OEC One CFD EUDAMED
OEC FDA UDI
Generic Name
Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
OEC One CFD EUDAMED
MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One CFD FDA UDI
Model / Reference
OEC One CFD EUDAMED
7999000PCM EUDAMED
One CFD FDA UDI
Description
MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One CFD FDA UDI

Identifiers

Primary DI / UDI-DI
00840682145541 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00297HX EUDAMED
510(k) Number
K182626 FDA UDI
K240828 FDA UDI
FDA Product Code
OWB FDA UDI
JAA FDA UDI
OXO FDA UDI
EMDN Code
Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
GMDN Term
Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

The OEC One CFD is a Class IIb computed fluoroscopy device, classified under nomenclature code Z11039017. It is an active imaging system designed for real-time X-ray visualization, enabling precise guidance during interventional procedures such as cardiac catheterization, peripheral vascular interventions, or electrophysiology studies. Its advanced fluoroscopy capabilities allow clinicians to visualize contrast agents, guide catheters, and assess anatomical structures with high resolution.

Supplied as a single-use or reusable system (as per facility reprocessing protocols), the OEC One CFD is intended for use in cardiac catheterization labs, interventional radiology suites, and electrophysiology labs. The device is non-sterile and non-implantable, with no latex components. It is equipped with a UDI (8406821BUG00297HX) and complies with FDA 510K and MDR regulations. Storage and handling should follow manufacturer guidelines to ensure optimal performance and safety.

Frequently asked questions

Is the OEC One CFD designed for single-use or can it be reused after cleaning and reprocessing?

The OEC One CFD is supplied as a system that can be used either as single-use or reused, depending on facility reprocessing protocols. The device itself is not labeled as reusable or single-use in its specifications, so reprocessing must follow established protocols to ensure safety and performance. Always adhere to manufacturer guidelines for cleaning and sterilization if reuse is intended.

What types of procedures is the OEC One CFD primarily intended to support in a clinical setting?

The OEC One CFD is an active imaging system designed for real-time X-ray visualization, making it ideal for guiding interventional procedures such as cardiac catheterization, peripheral vascular interventions, and electrophysiology studies. Its high-resolution fluoroscopy capabilities allow clinicians to visualize contrast agents, guide catheters, and assess anatomical structures during these procedures.

Does the OEC One CFD come with any latex components, and is it sterile?

The OEC One CFD is explicitly labeled as having no latex components, which is important for patients with latex allergies. However, it is also noted as non-sterile, meaning it should not be used directly on patients without appropriate sterilization or barrier precautions if needed for the procedure.

How should the OEC One CFD be stored to maintain its performance and safety?

The device should be stored and handled according to the manufacturer’s guidelines to ensure optimal performance and safety. While specific storage conditions are not detailed in the data, general best practices for fluoroscopy systems—such as protecting it from physical damage, extreme temperatures, and moisture—should be followed. Always refer to the manufacturer’s instructions for precise storage recommendations.

What regulatory pathways has the OEC One CFD followed for market authorization?

The OEC One CFD has undergone authorization through the FDA 510K process and complies with the EU Medical Device Regulation (MDR). These pathways confirm its compliance with applicable safety and performance standards in the United States and European markets, respectively. The device carries a UDI for traceability and regulatory tracking.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
GE HUALUN MEDICAL SYSTEMS CO. Ltd
EUDAMED SRN
CN-MF-000001189
Authorised Representative
GE Medical Systems SCS FR-AR-000000344

Sources (3)

  • EUDAMED ac8b99c0-775d-4c72-9f71-81bb5b2d20df 61 fields · synced Sep 18, 2026
  • FDA UDI ea6dfeb3-6cb1-4b36-9c81-e98266ec82e5 34 fields · synced May 30, 2026
  • FDA 510(k) K182626 1 fields · synced May 18, 2026