Cleared Special

K211665 - SONON Ultrasound Imaging System, Model: SONON300C (FDA 510(k) Clearance)

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

K211665 · Healcerion Co., Ltd. · Radiology device
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May 2022
Decision
349d
Days
Class 2
Risk

K211665 is an FDA 510(k) clearance for the SONON Ultrasound Imaging System, Model: SONON300C. 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 Healcerion Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 16, 2022 after a review of 349 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Healcerion Co., Ltd. devices

Submission Details

510(k) Number K211665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date May 16, 2022
Days to Decision 349 days
Submission Type Special
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
242d slower than avg
Panel avg: 107d · This submission: 349d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Gms Consulting Co., Ltd.
Jong Hyun Kim

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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