Cleared Abbreviated

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

Also marketed or referenced as:
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

All 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K211321.
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Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
K221300 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2022