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CT Contrast Delivery Systems Dual Shot alpha7

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref Many

by Nemoto Kyorindo Co., Ltd.

Identity

Trade Name
CT Contrast Delivery Systems DUAL SHOT alpha7 EUDAMED
DUAL SHOT alpha 7 FDA UDI
Generic Name
CT contrast medium injection system, line-powered, mobile FDA UDI
Device Name
CT Contrast Delivery Systems DUAL SHOT alpha7 EUDAMED
Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications. FDA UDI
Model / Reference
Many EUDAMED
170 FDA UDI
Description
Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications. FDA UDI

Identifiers

Primary DI / UDI-DI
04560138481707 EUDAMEDFDA UDI
Basic UDI-DI
B-04560138481707 EUDAMED
510(k) Number
K133189 FDA UDI
FDA Product Code
DXT FDA UDI
EMDN Code
Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
GMDN Term
CT contrast medium injection system, line-powered, mobile FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Market of Registration
Belgium 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The CT Contrast Delivery Systems Dual Shot Alpha7 is a Class IIb medical device classified under nomenclature code Z11039014. It is designed as an administrating medicine system, specifically for delivering contrast agents during computed tomography (CT) scans. This dual-shot mechanism enables precise, sequential injection of contrast media to enhance imaging clarity and diagnostic accuracy in vascular and organ studies.

This device is non-sterile, non-reusable, and intended for single-use administration of contrast agents. It is supplied with a unique Basic UDI (B-04560138481707) and is authorized under FDA 510K and MDD regulations. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety. The device is manufactured by Nemoto Kyorindo Co., Ltd., with distribution oversight by Medicor International NV/SA.

Frequently asked questions

What is the primary purpose of the CT Contrast Delivery Systems DUAL SHOT alpha7 and how does its dual-shot mechanism benefit imaging studies?

The CT Contrast Delivery Systems DUAL SHOT alpha7 is designed to administer contrast agents during CT scans, specifically enhancing vascular and organ imaging for clearer diagnostic results. Its dual-shot mechanism allows for precise, sequential injection of contrast media, which improves imaging clarity and accuracy by optimizing the timing and delivery of the contrast agent.

Is the CT Contrast Delivery Systems DUAL SHOT alpha7 intended for single-use or reusable applications, and what does this mean for clinical workflows?

The device is explicitly designed for single-use only, meaning each unit is intended to be used once and then discarded. This ensures sterility and safety, as it is non-sterile by design, and eliminates the need for reprocessing or maintenance between uses, simplifying clinical workflows and reducing contamination risks.

How should the CT Contrast Delivery Systems DUAL SHOT alpha7 be stored, and are there any specific handling requirements mentioned?

While the data does not specify exact storage conditions, the manufacturer’s guidelines must be followed to maintain functionality and safety. Since it is non-sterile and single-use, proper storage involves protecting it from contamination and environmental damage until use. Always refer to the manufacturer’s instructions for precise storage recommendations.

Who is responsible for distributing this device, and how can I verify its authenticity?

The device is distributed by Medicor International NV/SA, as indicated by the authorization records. To verify authenticity, check the Basic UDI (B-04560138481707) and ensure it matches the labeled unit. This UDI helps confirm the device’s legitimacy and traceability in compliance with regulatory requirements.

What regulatory pathways does the CT Contrast Delivery Systems DUAL SHOT alpha7 follow, and how does this affect its availability?

The device is authorized under FDA 510K and MDD (Medical Device Directive) regulations, meaning it has undergone regulatory review in both the U.S. and EU markets. This dual authorization supports its availability in jurisdictions adhering to these frameworks, ensuring compliance with local medical device standards.

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

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Nemoto Kyorindo Co., Ltd.
EUDAMED SRN
JP-MF-000004827
Authorised Representative
Medicor International NV/SA BE-AR-000003308

Sources (3)

  • EUDAMED dbcee49e-58b1-441b-80d5-f1d8de5be44e 61 fields · synced Sep 18, 2026
  • FDA UDI 5629bf3f-09db-4007-be39-39ccc95b3cb0 35 fields · synced May 30, 2026
  • FDA 510(k) K052633 1 fields · synced May 18, 2026