# AVIEW

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/aview-cls-usr-003-eu>
- Manufacturer: [Coreline Soft Co., Ltd.](https://devicerts.com/manufacturers/fda-fei-3015169361) (South Korea)
- Device class: Class IIb (EU MDR); Class IIa (EU MDR)
- EMDN: Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
- EMDN: Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

AVIEW is a Class IIb medical imaging device designed for diagnostic use in radiology. The device is manufactured by Coreline Soft Co., Ltd. and is not sterile, implantable, or reusable.

The AVIEW device is supplied as a standard medical device and is not intended for administering medicine or containing animal or human tissues. It is authorized under FDA 510K, MDD, and MDR regulations, with a reference number of CLS-USR-003(EU). The device is active and has a basic UDI of 88000253A001B2.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K243689 · issued 2025-03-19 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 88000253A001B2 · UDI-DI 08800025300114 · registered 2024-11-18 · status: Active
- **510(k)** · FDA 510(k) · United States · K214036 · issued 2022-12-23 · status: Active
- **510(k)** · FDA 510(k) · United States · K200714 · issued 2020-08-26 · status: Active
- **510(k)** · FDA 510(k) · United States · K171199 · issued 2018-10-31 · status: Active

## Recalls

No recall on record.

## Identity

- Model / reference: CLS-USR-003(EU) [EUDAMED]; CLS-2021-001 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800025300114 [EUDAMED]
- Basic UDI-DI: 88000253A001B2 [EUDAMED]; B-08800025300114 [EUDAMED]
- EMDN code: Z11069092 [EUDAMED]; Z110603 [EUDAMED]

## Classification

- Device class: Class IIb [EUDAMED]; Class IIa [EUDAMED]
- Special device type: Software [EUDAMED]
- EU registration type: Standard device [EUDAMED]; Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]

## Properties

- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: AVIEW, Coreline Soft Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/aview-cls-usr-003-eu (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/aview-cls-usr-003-eu.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/aview-cls-usr-003-eu
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.