Cleared Traditional

K210468 - SC1 Handheld Ultrasound Imaging System ...

K210468 is an FDA 510(k) clearance for SC1 Handheld Ultrasound Imaging System ..., manufactured by Fcu Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K210468 · Fcu Co., Ltd. · Radiology device
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Jul 2021
Decision
157d
Days
Class 2
Risk

K210468 is an FDA 510(k) clearance for the SC1 Handheld Ultrasound Imaging System (Model: SC1). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Fcu Co., Ltd. (Yuseong-Gu, KR). The FDA issued a Cleared decision on July 23, 2021 after a review of 157 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 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.

View all Fcu Co., Ltd. devices

FDA 510(k) Submission Details - K210468

510(k) Number K210468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2021
Decision Date July 23, 2021
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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