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FDA 510(k)

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K032640 · 2003-09-11

ApplicantU-Systems, Inc.
Decision Date2003-09-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM 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 2003-09-11 under 510(k) number K032640. 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 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM?

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-11. The listed applicant is U-Systems, Inc.. The 510(k) number is K032640.

When did FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2003-09-11, under 510(k) number K032640.

Who is the listed applicant for FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM?

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 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM 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.

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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.

K052355AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUSK022517USI-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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