Planmed Sophie, Planmed Sophie Classic
FDA 510(k)Class II (US FDA 510(k))
by Planmed Oy
Identifiers
- 510(k) Number
- K010116 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)
This device is a mammographic X-ray system, specifically the Planmed Sophie and Planmed Sophie Classic models, designed for radiographic imaging of the breast. It is classified as a Class II medical device under FDA regulation 892.1710 and is used in radiology for diagnostic imaging procedures.
The system is supplied as a reusable unit intended for use in clinical settings such as hospitals or imaging centers. It requires appropriate installation, maintenance, and operator training. The device received FDA 510(k) clearance (K010116) on March 15, 2001, and is substantially equivalent to a legally marketed predicate device.
Frequently asked questions
What is the Planmed Sophie used for?
The Planmed Sophie and Sophie Classic are mammographic X-ray systems designed for radiographic imaging of the breast in diagnostic procedures, used in radiology to produce images for clinical evaluation of breast tissue.
Is the Planmed Sophie a reusable or single-use device?
The Planmed Sophie and Sophie Classic are supplied as reusable units, meaning they are intended for repeated use in clinical environments such as hospitals or imaging centers, provided they undergo proper installation, maintenance, and operator training between uses.
What regulatory pathway was used for the Planmed Sophie?
The Planmed Sophie and Sophie Classic received FDA 510(k) clearance under submission number K010116 on March 15, 2001, demonstrating substantial equivalence to a legally marketed predicate device under FDA regulation 892.1710 for mammographic X-ray systems.
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 TECHNICAL MANUAL Pdf Download | ManualsLib, Planmed Oy, Planmed - Sophie Classic Community, Manuals and Specifications | MedWrench
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010116 | Class II | Active |
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Manufacturer
- Manufacturer
- Planmed Oy
Sources (1)
- FDA 510(k) K010116 24 fields · synced Sep 24, 2026