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FDA 510(k)

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K091518 · 2009-06-18

ApplicantMcube Technology Co., Ltd.
Decision Date2009-06-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM 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 2009-06-18 under 510(k) number K091518. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM?

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K091518.

When did CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2009-06-18, under 510(k) number K091518.

Who is the listed applicant for CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM?

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-500 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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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)K111021CUBESCAN / BIOCON-700

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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