Cleared Traditional

K153581 - Bladder Scanner

K153581 is an FDA 510(k) clearance for Bladder Scanner, manufactured by Caresono Technology Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K153581 · Caresono Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
115d
Days
Class 2
Risk

K153581 is an FDA 510(k) clearance for the Bladder Scanner. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Caresono Technology Co., Ltd. (Dangdong, TW). The FDA issued a Cleared decision on April 8, 2016 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153581

510(k) Number K153581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date April 08, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Shenzhen Hlongmed Biotech Company
Long Yang

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 760
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K153581.
Acclarix AX8 Diagnostic Ultrasound System
K161300 · Edan Instruments, Inc. · May 2016
Enovare Ultrasound System
K153620 · Oreon Technologies, Inc. · May 2016
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
K160792 · The Prometheus Group · Apr 2016
SpeqT
K160420 · Signostics Limited · Mar 2016
FibroScan 530 Compact
K160524 · Echosens · Mar 2016
ArcScan Insight 100
K153416 · Arcscan, Inc. · Feb 2016