Cleared Abbreviated

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C (K172750) - FDA 510(k) Clearance

Also marketed or referenced as:
UProbe-L BProbe)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K172750 · Guangzhou Sonostar Technologies Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
169d
Days
Class 2
Risk

K172750 is an FDA 510(k) clearance for the Wireless Probe Type Ultrasound Scanner (Model:UProbe-C. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Guangzhou Sonostar Technologies Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 28, 2018 after a review of 169 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Guangzhou Sonostar Technologies Co., Ltd. devices

Submission Details

510(k) Number K172750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date February 28, 2018
Days to Decision 169 days
Submission Type Abbreviated
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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Wenzhou Cytech Information Service Co., Ltd.
Helen Nan

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 215
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K172750.
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