U-Systems
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE HealthCareLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
- 510(k) clearances: 7
- Device recalls: 1
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 16, 2013 | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer sClass II · Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the In | Device recalls |
| Aug 7, 2008 | MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUSK080930 · IYO | 510(k) clearances |
| Sep 14, 2005 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUSK052355 · IYO | 510(k) clearances |
| Sep 11, 2003 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEMK032640 · IYO | 510(k) clearances |
| Dec 24, 2002 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORYK022517 · IYN | 510(k) clearances |
| Jun 5, 2002 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000K013902 · IYN | 510(k) clearances |
| Apr 8, 2002 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000K013848 · IYN | 510(k) clearances |
| Jan 18, 2001 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000K003479 · IYN | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- gehealthcare.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built