Cleared Traditional

K171591 - CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

K171591 is an FDA 510(k) clearance for CUBEScan BioCon-900 (Bladder Volume Mea..., manufactured by Mcube Technology Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K171591 · Mcube Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
22d
Days
Class 2
Risk

K171591 is an FDA 510(k) clearance for the CUBEScan™ BioCon-900 (Bladder Volume Measurement System). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Mcube Technology Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on June 22, 2017 after a review of 22 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

FDA 510(k) Submission Details - K171591

510(k) Number K171591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date June 22, 2017
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 632
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K171591.
Scanmate Flex
K171301 · Dgh Technology, Inc. · Jul 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
K171824 · Edan Instruments, Inc. · Jul 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · Siemens Medi Cal Solutions, Inc. · Jul 2017
MELODY, Remote Control System for Ultrasound Probe
K161354 · Adecho Tech · Jun 2017
QT Ultrasound Breast Scanner-1
K162372 · Qt Ultrasound, LLC · Jun 2017
FFR V2.5
K170133 · Philips Volcano · May 2017