Senograph Ds, Senograph Essenstial
510(k) K103485
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103485 | Date6 Oct 2011 | 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- Withdrawn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
- MUE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1715
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Senograph DS and Senograph Essential are full-field digital mammography systems that use X-ray technology for breast imaging. These systems are designed for use in radiology departments for mammographic examinations.
The systems are manufactured by General Electric Company and have received FDA 510(k) clearance with K-number K103485. They are Class II devices regulated under product code MUE and are intended for single breast compression imaging with standard and higher energy spectrum X-ray exposures.
Other devices from General Electric Co.
Questions
AI-generated answers, 6 Oct 2026
What is the Senograph DS used for?
The Senograph DS is used for mammographic examinations in radiology departments, utilizing X-ray technology for breast imaging.
Is the Senograph DS a single-use device?
The Senograph DS is intended for single breast compression imaging, but it is not specified as a single-use device.
What type of clearance has the Senograph DS received?
The Senograph DS has received FDA 510(k) clearance with K-number K103485, indicating it is substantially equivalent to a predicate device.
What product code does the Senograph DS fall under?
The Senograph DS falls under product code MUE, which is regulated under the medical specialty description of Radiology.