Cleared Traditional

Aco Apache Ultrasound System (K231509) - FDA 510(k) Clearance

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

K231509 · Aco Healthcare Co., Ltd. · Radiology device
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Oct 2023
Decision
152d
Days
Class 2
Risk

K231509 is an FDA 510(k) clearance for the Aco Apache Ultrasound System. 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 Aco Healthcare Co., Ltd. (Taoyuan City, TW). The FDA issued a Cleared decision on October 24, 2023 after a review of 152 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 Aco Healthcare Co., Ltd. devices

Submission Details

510(k) Number K231509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2023
Decision Date October 24, 2023
Days to Decision 152 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
45d slower than avg
Panel avg: 107d · This submission: 152d
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 K231509.
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
K232145 · Siemens Medical Solutions USA, Inc. · Oct 2023
TE Air Diagnostic Ultrasound System
K231685 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2023
Lumify Diagnostic Ultrasound System
K232500 · Philips Ultrasound · Oct 2023
Ultrasound System 1300
K231764 · Bk Medical Aps · Oct 2023
Clarius Ultrasound Scanner
K232704 · Clarius Mobile Health Corp. · Oct 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
K231772 · Samsung Medison Co., Ltd. · Oct 2023