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Planmed Clarity 2D and Clarity S

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192317

by Planmed Oy

Identifiers

510(k) Number
K192317 FDA 510(k)
FDA Product Code
MUE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1715 FDA 510(k)
Regulation Number
892.1715 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Planmed Clarity 2D and Clarity S are full-field digital mammography systems designed for breast imaging. Classified as a full-field digital X-ray mammographic system, these devices produce high-resolution digital images of breast tissue to aid in the detection and diagnosis of breast abnormalities, including calcifications and masses.

These systems are intended for use in radiology departments and are supplied as reusable medical devices. They are regulated under the FDA’s 510(k) pathway with a traditional review process, classified as Class II devices under the Medical Device Reporting (MDR) and Medical Device Directive (MDD). The Clarity 2D and Clarity S operate with multiple FEI numbers (e.g., 3001722928, 3009717300) and are authorized for FDA clearance, MDD compliance, and MDR registration, ensuring adherence to stringent regulatory standards for imaging equipment.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Planmed Oy

Sources (2)

  • FDA 510(k) K192317 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026