U-Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What U-Systems, Inc. makes
U-Systems, Inc. manufactures diagnostic ultrasound systems, including portable and automated models such as the USI-2000 series and the ABUS automated breast ultrasound system. Their portfolio also includes full-field breast imaging (FFBU) diagnostic ultrasound systems designed for targeted breast examinations.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) registry, adhering to U.S. medical device compliance standards.
Catalogue
U-Systems Diagnostic Ultrasound System Usi-2000 Ref K013902
510(k) 510(k)U-Systems Ultrasound System Usi-2000 Ref K003479
510(k) 510(k)- 510(k) 510(k)
U-Systems Diagnostic Ultrasound System U-2000 Ref K013848
510(k) 510(k)Automated Breast Ultrasound System, Model Abus Ref K052355
510(k) 510(k)- 510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by U-Systems, Inc., initiated on 2013-05-16. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 16 May 2013 Z-1587-2013 Class II Terminated Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].
Frequently asked questions
How many devices does U-Systems, Inc. have in the registry?
The registry currently lists 6 devices for U-Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list U-Systems, Inc.'s devices?
Among its 6 most recently registered devices, U-Systems, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do U-Systems, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for U-Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for U-Systems, Inc.?
FDA recall records list 1 recall initiated by U-Systems, Inc., the most recent initiated on 2013-05-16. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from U-Systems, Inc. in the registry?
The most recently registered devices listed for U-Systems, Inc. include U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000, U-SYSTEMS ULTRASOUND SYSTEM USI-2000, USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY and U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000.