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Suitestensa

by Ebit Srl

510(k) K163668

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163668↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK163668 Date23 Jun 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Suitestensa is a radiology information system (RIS) designed to manage, store, and facilitate the workflow of imaging studies and related data within radiology departments. It integrates with imaging modalities to ensure efficient handling of patient records, reports, and diagnostic information, supporting structured radiology practice.

The system is supplied as a software solution for use in radiology settings and is intended for single-user or multi-user deployment depending on the configuration. Authorized under FDA 510(k) clearance (K163668) and MDR compliance, Suitestensa operates as a Class II medical device. It requires appropriate IT infrastructure for installation and maintenance, with no specified sterility or single-use constraints.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of radiology departments can use Suitestensa, and how is it deployed within those settings?

    Suitestensa is designed for radiology departments that need to manage imaging workflows, patient records, and diagnostic reports efficiently. It is supplied as a software solution, meaning it requires installation on an appropriate IT infrastructure to function. Deployment can be configured for either single-user or multi-user environments, depending on the specific needs of the radiology department. Since it integrates with imaging modalities, it is best suited for facilities using digital radiology systems.

  • Is Suitestensa intended for single-use or reusable applications, and does it require sterilization?

    Suitestensa is a software-based radiology information system, so it does not involve physical devices that require sterilization or single-use constraints. It is designed for repeated use within radiology departments, as long as the underlying IT infrastructure is properly maintained and updated. Sterility is not applicable, as it is a digital solution.

  • How does Suitestensa integrate with existing imaging equipment, and what kind of technical setup is needed?

    Suitestensa integrates with imaging modalities to streamline workflows, but the exact technical setup depends on the radiology department’s existing IT infrastructure. Since it is a software solution, it requires compatible hardware (servers, workstations) and network connectivity to function. The system is not a standalone hardware device, so no additional physical installation beyond standard IT deployment is specified.

  • What regulatory pathways does Suitestensa follow, and what class does it belong to under medical device regulations?

    Suitestensa is authorized under both FDA 510(k) clearance (K163668) and MDR compliance, confirming its regulatory standing. It is classified as a Class II medical device, which reflects its role in managing radiology workflows and patient data. The classification is based on its intended use in structured radiology practice, not on physical risk factors.