Cleared Traditional

K091518 - CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOU...

K091518 is the FDA 510(k) clearance for CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOU... by Mcube Technology Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K091518 · Mcube Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
27d
Days
Class 2
Risk

K091518 is an FDA 510(k) clearance for the CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Mcube Technology Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mcube Technology Co., Ltd. devices

Submission Details

510(k) Number K091518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date June 18, 2009
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 388
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K091518.
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K102991 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · Hitachi Medical Systems America, Inc. · Jun 2010
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · Aloka Co., Ltd. · Nov 2009
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K082229 · Volcano Corporation · Oct 2008
ACUSON X300 ULTRASOUND SYSTEM
K072676 · Siemens Medical Solutions USA, Inc. · Dec 2007
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
K072797 · General Electric Co. · Oct 2007