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Aview Lcs 1.1

by Coreline Soft Co., Ltd.

Aview Lcs 1.1 is a radiological PACS-dedicated management software (FDA Class II) made by Coreline Soft Co., Ltd., cleared under FDA 510(k) K201710 on 16 Oct 2020 and listed in FDA GUDID since 9 Aug 2021 (UDI-DI 08800025300084), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K201710

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800025300084 UDI-DI Date9 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201710 Date16 Oct 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201710 decided 16 Oct 2020 Active
  • FDA GUDID UDI-DI 08800025300084 listed 9 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201710
  2. Listed FDA GUDID 08800025300084

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aview Lcs
Generic name
Radiological PACS-dedicated management software
Model / reference
1.1
Primary DI / UDI-DI
08800025300084
510(k) Number
FDA product code
LLZ, JAK
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Coreline Soft Co., Ltd.

See all devices from Coreline Soft Co., Ltd. →

Properties

Other properties (15, all answered No)