Cleared Traditional

LELTEK Ultrasound Imaging System (Model: LU700 Series) (K210432) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210432 · Leltek, Inc. · Radiology device
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Nov 2021
Decision
264d
Days
Class 2
Risk

K210432 is an FDA 510(k) clearance for the LELTEK Ultrasound Imaging System (Model: LU700 Series). 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 Leltek, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on November 3, 2021 after a review of 264 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Leltek, Inc. devices

Submission Details

510(k) Number K210432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2021
Decision Date November 03, 2021
Days to Decision 264 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
157d slower than avg
Panel avg: 107d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K210432.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
K212265 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2021
Clarius Ultrasound Scanner
K213436 · Clarius Mobile Health Corp. · Nov 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
K212900 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
K212704 · Philips Medical Systems · Sep 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · Esaote, S.P.A. · Sep 2021
Versana Premier
K210438 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2021