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Aview 1.1

by Coreline Soft Co., Ltd. 2 variants

Aview 1.1 is a Class II device made by Coreline Soft Co., Ltd., cleared under FDA 510(k) K200714 on 26 Aug 2020 and listed in FDA GUDID since 9 Aug 2021 (UDI-DI 08800025300077), 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) K200714

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 Number08800025300077 UDI-DI Date9 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK200714 Date26 Aug 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200714 decided 26 Aug 2020 Active
  • FDA GUDID UDI-DI 08800025300077 listed 9 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200714
  2. Listed FDA GUDID 08800025300077

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aview
Generic name
Radiological PACS-dedicated management software
Model / reference
1.1
Primary DI / UDI-DI
08800025300077
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

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Other devices from Coreline Soft Co., Ltd.

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Properties

Other properties (15, all answered No)