Cleared Abbreviated

K211321 - Wireless Probe Type Ultrasound Scanner (Model: CProbe (FDA 510(k) Clearance)

Also includes:
Type: Type C, Type L, Type CT, Type CL)

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

K211321 · Guangzhou Sonostar Technologies Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
531d
Days
Class 2
Risk

K211321 is an FDA 510(k) clearance for the Wireless Probe Type Ultrasound Scanner (Model: CProbe. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Guangzhou Sonostar Technologies Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 13, 2022 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Guangzhou Sonostar Technologies Co., Ltd. devices

Submission Details

510(k) Number K211321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date October 13, 2022
Days to Decision 531 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
424d slower than avg
Panel avg: 107d · This submission: 531d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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