Planmed Sophie Mammographic X-Ray Unit
FDA 510(k)Class II (US FDA 510(k))
by Planmed Oy
Identifiers
- 510(k) Number
- K951883 FDA 510(k)
- FDA Product Code
- IZH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1710 FDA 510(k)
- Regulation Number
- 892.1710 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Planmed Sophie Mammographic X-Ray Unit is a mammographic imaging system designed for breast cancer screening and diagnosis. It produces high-resolution X-ray images of breast tissue, enabling radiologists to detect abnormalities such as calcifications, masses, or architectural distortions. This device adheres to the classification of a mammographic X-ray system, providing critical diagnostic support in radiology settings.
This unit is supplied as a reusable medical device and is intended for use in clinical radiology departments. It operates under FDA clearance (510K) and is classified as a Class II device, adhering to regulatory standards for mammographic imaging. The system requires proper maintenance, calibration, and storage in a controlled environment to ensure accurate and reliable performance. No specific sterility requirements are noted, but standard infection control protocols must be followed.
Frequently asked questions
What is the Planmed Sophie Mammographic X-Ray Unit used for?
The Planmed Sophie Mammographic X-Ray Unit is specifically designed for breast cancer screening and diagnosis. It produces high-resolution X-ray images of breast tissue, allowing radiologists to identify abnormalities such as calcifications, masses, or architectural distortions. This capability is critical for early detection and accurate diagnosis of breast conditions, supporting clinical decision-making in radiology settings.
Is the Planmed Sophie Mammographic X-Ray Unit a single-use or reusable device?
The Planmed Sophie Mammographic X-Ray Unit is a reusable medical device. As such, it is intended for repeated use in clinical radiology departments, provided it undergoes proper maintenance, calibration, and cleaning to ensure consistent performance and safety. Standard infection control protocols must also be followed during use.
What regulatory approval does the Planmed Sophie Mammographic X-Ray Unit hold?
The Planmed Sophie Mammographic X-Ray Unit holds FDA clearance under the 510(k) pathway, specifically classified as a Class II device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory standards for mammographic imaging systems in the United States.
How should the Planmed Sophie Mammographic X-Ray Unit be stored?
The Planmed Sophie Mammographic X-Ray Unit requires storage in a controlled environment to maintain its accuracy and reliability. While no specific sterility requirements are noted, adherence to standard infection control protocols is essential. The device should be kept in a clean, dry, and protected space, away from direct sunlight or extreme temperatures, to prevent damage and ensure optimal performance for clinical use.
Does the Planmed Sophie Mammographic X-Ray Unit require any special maintenance?
Yes, the Planmed Sophie Mammographic X-Ray Unit requires regular maintenance and calibration to ensure its performance remains accurate and reliable. Proper maintenance includes routine checks of the imaging system, alignment of components, and adherence to manufacturer guidelines for servicing. These steps are vital to uphold the device’s diagnostic precision and longevity in clinical radiology settings.
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: PLANMED Sophie Mammographic X-ray unit Technical Manual, PLANMED SOPHIE TECHNICAL MANUAL Pdf Download | ManualsLib, Planmed Sophie Mammographic X-ray Unit User Manual, Planmed Sophie Mammography X-ray Unit Technical Manual, PDF Planmed Sophie User Manual.pdf - iFixit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951883 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Planmed Oy
Sources (1)
- FDA 510(k) K951883 24 fields · synced Oct 1, 2026