ABVS Workplace
by Siemens AG Medical Solutions
510(k) K092067
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092067 | Date18 Sep 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The ABVS Workplace is an offline image viewing workstation designed for breast ultrasound imaging. Classified as a system for image processing and radiological applications, it is intended for reviewing B-mode ultrasound images acquired from automatic or handheld linear transducers. This device facilitates diagnostic evaluation by providing a dedicated platform for analyzing breast ultrasound scans in a clinical setting.
Supplied as a standalone workstation, the ABVS Workplace is intended for use in radiology departments or breast imaging clinics. It operates offline, requiring no direct connection to a Picture Archiving and Communication System (PACS) during image review. The device is classified under product code LLZ and has received FDA clearance via a 510(k) submission (K092067), with a decision of Substantially Equivalent under the Radiology Advisory Committee. No specific sterility or single-use requirements are noted; its use is regulated under Class II – Special Controls for radiological image processing systems.
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ABVS Workplace designed for?
The ABVS Workplace is specifically designed for reviewing B-mode ultrasound images acquired from automatic or handheld linear transducers in breast ultrasound imaging. It provides a dedicated platform for analyzing breast ultrasound scans in clinical settings, such as radiology departments or breast imaging clinics, to aid in diagnostic evaluations.
How is the ABVS Workplace supplied and does it require a PACS connection?
The ABVS Workplace is supplied as a standalone workstation, meaning it does not require a direct connection to a Picture Archiving and Communication System (PACS) during image review. This offline capability allows for independent and flexible use in clinical environments.
Is the ABVS Workplace single-use or reusable, and what are its sterility requirements?
The ABVS Workplace is not classified as single-use or requiring sterility for its primary function as an image viewing workstation. It is intended for repeated use in clinical settings, adhering to standard radiological image processing system regulations under Class II – Special Controls.
What regulatory pathway does the ABVS Workplace follow?
The ABVS Workplace received FDA clearance through a 510(k) submission (K092067) under the Radiology Advisory Committee. The decision was classified as Substantially Equivalent, indicating it meets the regulatory standards for radiological image processing systems as defined by the FDA.
Can the ABVS Workplace be used with any type of ultrasound transducer?
The ABVS Workplace is intended for reviewing B-mode ultrasound images acquired specifically from automatic or handheld linear transducers. While it is designed to support these types of transducers, compatibility with other transducer types should be verified to ensure optimal performance and diagnostic accuracy.