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AVIEW

by Coreline Soft Co., Ltd.

Ref CLS-USR-003(EU), CLS-2021-001

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243689↗

+3 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK243689 Date19 Mar 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number88000253A001B2 Basic UDI-DI 08800025300114UDI-DIDate18 Nov 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243689 decided 19 Mar 2025 Active· +3 more in the status table
  • EUDAMED Basic UDI-DI 88000253A001B2 registered 18 Nov 2024 Active

Timeline

5 dated events

  1. Cleared FDA 510(k) K171199
  2. Cleared FDA 510(k) K200714
  3. Cleared FDA 510(k) K214036
  4. Registered EUDAMED 88000253A001B2
  5. Cleared FDA 510(k) K243689

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
CLS-USR-003(EU), CLS-2021-001
Primary DI / UDI-DI
08800025300114
Basic UDI-DI
88000253A001B2, B-08800025300114
EMDN code
Z11069092, Z110603
Device class
Class IIb
Class IIa
Special device type
Software
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011555
Authorised representative
JaviTech e.K. DE-AR-000005875

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.

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.

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Coreline Soft Co., Ltd.

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Properties

Other properties (14, all answered No)