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Seno Advantage

by Ge Medical Systems W-400

510(k) K033400

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033400 Date4 Dec 2003ClearedStatusActive

Recalls

6 recalls · FDA

    • Terminated Z-2257-2013 FDA Class II initiated 20 Sep 2012

    GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.

    • Terminated Z-0125-2013 FDA Class II initiated 24 May 2012

    GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.

    • Terminated Z-0095-2013 FDA Class II initiated 24 May 2012

    GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv

    • Terminated Z-3012-2011 FDA Unclassified (pre-2012) initiated 31 May 2011

    GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. Two different

    • Terminated Z-1747-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2010

    GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may a

    • Terminated Z-0476-2011 FDA Unclassified (pre-2012) initiated 28 Aug 2009

    The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Seno Advantage is a Class II X-ray system designed for mammography, providing high-resolution imaging for breast tissue evaluation. It is classified under the FDA’s product code LLZ and is intended for use in radiology departments to capture detailed diagnostic images.

This device is supplied as a traditional X-ray system with a dedicated keypad for enhanced productivity, supported by an HP XW8000 Workstation for image processing. It is cleared for single-use or reusable components as defined by manufacturer protocols, with no explicit MRI safety classification noted. Storage and handling follow standard radiology protocols, and its regulatory status includes FDA 510(k) clearance under K-number K033400, filed in 2003.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical facilities or departments would typically use the Seno Advantage mammography system, and why is it suited for those environments?

    The Seno Advantage is designed specifically for radiology departments, particularly those specializing in breast imaging. Its high-resolution X-ray capabilities make it ideal for detailed evaluation of breast tissue, which is essential in diagnostic settings where early detection of abnormalities is critical. The system’s dedicated keypad and integration with an HP XW8000 Workstation enhance workflow efficiency, reducing processing time and improving productivity—key factors in busy clinical environments.

  • How is the Seno Advantage system supplied, and what considerations should be made regarding its components?

    The Seno Advantage is supplied as a complete X-ray mammography system, including the imaging unit and a dedicated keypad for streamlined operation. Components can be used either as single-use or reusable, depending on manufacturer protocols. Clinicians should follow established radiology protocols for storage and handling to ensure optimal performance and compliance with safety standards. There is no explicit MRI safety classification mentioned, so MRI environments should verify compatibility separately.

  • What regulatory pathway was followed for the Seno Advantage, and what does this mean for its use in clinical settings?

    The Seno Advantage received FDA 510(k) clearance under K-number K033400, filed in 2003, with a decision classified as substantially equivalent (SESE) under the product code LLZ for mammography systems. This means the device was evaluated by the FDA’s Radiology Advisory Committee (RA) and deemed comparable to legally marketed predecessors, ensuring it meets established safety and effectiveness standards for diagnostic breast imaging in radiology departments.

  • Are there different models or sizes available for the Seno Advantage, and if so, how might they differ?

    The provided data does not specify multiple models or sizes for the Seno Advantage, focusing instead on its core design as a high-resolution mammography X-ray system. However, the system’s integration with an HP XW8000 Workstation suggests flexibility in image processing capabilities, which may indirectly support varying clinical workflows. For precise model or size details, consulting the manufacturer’s technical documentation or support team would be advisable.