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FDA 510(k)

CUBESCAN / BIOCON-700

K-Number: K111021 · 2011-04-27

ApplicantMcube Technology Co., Ltd.
Decision Date2011-04-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CUBESCAN / BIOCON-700 is the device name listed in this FDA 510(k) record. The listed applicant is Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-04-27 under 510(k) number K111021. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUBESCAN / BIOCON-700?

CUBESCAN / BIOCON-700 is a medical device that received FDA 510(k) clearance on 2011-04-27. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K111021.

When did CUBESCAN / BIOCON-700 receive FDA 510(k) clearance?

CUBESCAN / BIOCON-700 received FDA 510(k) clearance on 2011-04-27, under 510(k) number K111021.

Who is the listed applicant for CUBESCAN / BIOCON-700?

The FDA 510(k) record lists Mcube Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUBESCAN / BIOCON-700?

The FDA product code for CUBESCAN / BIOCON-700 is ITX.

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Other records listing Mcube Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201995CUBEScan BioCon-1100K200749CUBEScan BioCon-900SK200548CUBEScan BioCon-1100K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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