Cleared Special

K052355 - AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

K052355 is an FDA 510(k) clearance for AUTOMATED BREAST ULTRASOUND SYSTEM, manufactured by U-Systems, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 16-day FDA review.

K052355 · U-Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
16d
Days
Class 2
Risk

K052355 is an FDA 510(k) clearance for the AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by U-Systems, Inc. (San Jose, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052355

510(k) Number K052355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date September 14, 2005
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 849
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K052355.
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900
K053346 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2005
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY)
K053325 · Mediwatch, Ltd. · Dec 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · Volcano Corporation · Dec 2005
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
K051920 · Volcano Corporation · Aug 2005
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K052113 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2005
AVISO OPHTHALMIC ULTRASOUND SYSTEM
K051851 · Quantel Medical · Aug 2005
K052355 · AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Download PDF FDA Summary U-Systems, Inc.