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Clisis Systems Discovery RF180

by General Medical Merate S.P.A. Italy 510(k)

510(k) K213081 Product code IZF

Overview

The Clisis Systems Discovery RF180 is a Class II mammography system, classified as a System, X-ray, Tomographic device. It is designed for use in radiology departments for diagnostic imaging procedures.

The device is manufactured by General Medical Merate S.P.A. and received FDA 510(k) clearance on October 26, 2021, with K-number K213081. It is supplied as a complete system and is subject to special controls as a Class II device.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213081 Date26 Oct 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
IZF
FDA applicant
General Medical Merate S.P.A
Device Class
Class II
Regulation
21 CFR Part 892.1740
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from General Medical Merate S.P.A.

See all devices from General Medical Merate S.P.A. →

Questions

  • What is the Clisis Systems Discovery RF180 used for?

    The Discovery RF180 is a Class II mammography system designed for use in radiology departments for diagnostic imaging procedures. It is classified as a System, X-ray, Tomographic device specifically for mammography applications.

  • How is the Discovery RF180 supplied and what are its regulatory approvals?

    The device is supplied as a complete system and received FDA 510(k) clearance on October 26, 2021, with K-number K213081. It is classified as a Class II device subject to special controls.

  • What are the specifications and model details of the Discovery RF180?

    The Discovery RF180 is manufactured by General Medical Merate S.P.A. with product code IZF. It has a decision code of SESE (Substantially Equivalent) and was reviewed by the Radiology Advisory Committee (RA). The device is designed for diagnostic imaging in radiology departments.

  • Is the Discovery RF180 a single-use device or can it be reused?

    The device information does not specify whether the Discovery RF180 is single-use or reusable. As a mammography system, it is typically designed for multiple patient examinations following proper sterilization and maintenance protocols according to manufacturer guidelines.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K213081 24 fields · synced 22 Oct 2026