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CUBEScan BioCon-1100

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200548

by Mcube Technology Co., Ltd.

Identifiers

510(k) Number
K200548 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CUBEScan BioCon-1100 is a computed tomography (CT) scanner designed for small animal imaging, enabling high-resolution, three-dimensional visualization of biological specimens. It is classified under the product code IYO and is intended for research applications requiring detailed internal imaging of small animals or biological samples.

This device is supplied as a research instrument and is not intended for clinical patient use. It is regulated under the FDA’s 510(k) pathway with a clearance decision dated 2020-03-27, classified as substantially equivalent under the Radiology advisory committee. The system is manufactured by Mcube Technology Co., Ltd., and its specifications are tailored for laboratory or preclinical research environments.

Frequently asked questions

What types of biological specimens or small animals can the CUBEScan BioCon-1100 image, and is it suitable for clinical patient use?

The CUBEScan BioCon-1100 is specifically designed for research applications and enables high-resolution, three-dimensional imaging of small animals or biological specimens. It is not intended for clinical patient use, as explicitly stated in its description. The device’s purpose is to provide detailed internal visualization for preclinical or laboratory research environments, such as studying small animal models or biological samples.

How is the CUBEScan BioCon-1100 regulated, and what does its FDA clearance mean for buyers?

The CUBEScan BioCon-1100 is regulated under the FDA’s 510(k) pathway, with a clearance decision dated March 27, 2020. It was determined substantially equivalent to a predicate device under the Radiology advisory committee (RA), meaning it meets FDA standards for safety and effectiveness as a research CT scanner for small animals. Buyers should note this clearance applies only to its research use, not clinical patient imaging.

Is the CUBEScan BioCon-1100 supplied as a standalone system, or does it require additional components for operation?

The CUBEScan BioCon-1100 is supplied as a complete research instrument tailored for laboratory or preclinical settings. While the provided data does not specify exact accessories, its design implies it is intended for standalone use in controlled research environments. Buyers should confirm compatibility with their facility’s infrastructure (e.g., power, networking) and any required software or calibration tools.

What does the product code IYO indicate about the CUBEScan BioCon-1100’s regulatory classification?

The product code IYO classifies the CUBEScan BioCon-1100 under radiological imaging devices for research purposes. This classification is used by the FDA to categorize submissions and does not imply clinical use—it simply denotes the device’s regulatory filing route (e.g., 510(k)) and its intended application in preclinical or laboratory settings, not patient care.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mcube Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K200548 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026