Senographe 2000D Full Field Digital Mammography System
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM FDA PMA
- Generic Name
- Full field digital, system, x-ray, mammographic FDA PMA
Identifiers
- PMA Number
- P990066 FDA PMA
- FDA Product Code
- MUE FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.1715 FDA PMA
- Regulation Number
- 892.1715 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Senographe 2000D Full Field Digital Mammography System is a full-field digital, x-ray mammographic imaging device designed for breast cancer screening and diagnosis. It captures high-resolution digital images of breast tissue, enabling radiologists to detect abnormalities such as microcalcifications and masses with enhanced clarity and detail compared to traditional screen-film systems.
This system is intended for use in radiology departments and is supplied as a complete imaging solution, including the x-ray generator, detector, and associated software for image acquisition and review. It is a reusable, non-sterile device and is classified as a Class II medical device under FDA regulations (PMA P990066). The system operates within standard MRI safety guidelines for non-MRI environments and requires proper calibration and maintenance to ensure accurate imaging performance.
Frequently asked questions
What is the primary clinical purpose of the Senographe 2000D Full Field Digital Mammography System, and how does it differ from traditional screen-film systems?
The Senographe 2000D is designed specifically for breast cancer screening and diagnosis by capturing high-resolution digital images of breast tissue. Unlike traditional screen-film systems, it provides enhanced clarity and detail, allowing radiologists to more effectively detect abnormalities such as microcalcifications and masses. This digital capability improves diagnostic accuracy and reduces the need for repeat imaging.
Is the Senographe 2000D a single-use or reusable device, and what does that mean for maintenance and cleaning?
The Senographe 2000D is a reusable, non-sterile device. This means it is intended for repeated use across multiple patients, but it requires regular cleaning and maintenance to ensure proper functionality and hygiene. The manufacturer provides guidelines for calibration and upkeep to maintain imaging performance and safety standards.
How is the Senographe 2000D supplied, and what components are included in the full imaging solution?
The Senographe 2000D is supplied as a complete imaging solution, including the x-ray generator, detector, and associated software for image acquisition and review. This setup ensures all necessary components for digital mammography are integrated into one system, simplifying installation and operation in radiology departments.
What regulatory pathway was followed for the approval of the Senographe 2000D, and what does this mean for its use in clinical settings?
The Senographe 2000D underwent a Premarket Approval (PMA) process through the FDA, with approval granted under PMA number P990066. This pathway is typically reserved for higher-risk medical devices, ensuring rigorous evaluation of safety and effectiveness before clinical use. Clinicians can rely on this approval as evidence of the system’s compliance with stringent regulatory standards for breast imaging.
Are there any specific safety guidelines or environmental requirements for operating the Senographe 2000D?
The system operates within standard MRI safety guidelines for non-MRI environments, meaning it is safe to use in areas where MRI procedures are not performed. Proper calibration and maintenance are required to ensure accurate imaging performance, and adherence to these guidelines helps maintain both safety and diagnostic reliability for patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Senographe 2000D - Full-field digital mammography system, GE HealthCare - Senographe 2000D - MedWrench, Senographe DS - Versatile digital mammography station, Three GE Digital Senographe Mammography Systems Compared, Comparison of Full-Field Digital Mammography and Screen-Film ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990066 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA PMA P990066 24 fields · synced Oct 6, 2026