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FDA 510(k)

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

K-Number: K052355 · 2005-09-14

ApplicantU-Systems, Inc.
Decision Date2005-09-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS is the device name listed in this FDA 510(k) record. The listed applicant is U-Systems, Inc.. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K052355. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS?

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is U-Systems, Inc.. The 510(k) number is K052355.

When did AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS receive FDA 510(k) clearance?

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS received FDA 510(k) clearance on 2005-09-14, under 510(k) number K052355.

Who is the listed applicant for AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS?

The FDA 510(k) record lists U-Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS?

The FDA product code for AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS is IYO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing U-Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032640FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEMK022517USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORYK013902U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000K013848U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000K003479U-SYSTEMS ULTRASOUND SYSTEM USI-2000

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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