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Aview Cac 1.1

by Coreline Soft Co., Ltd.

Aview Cac 1.1 is a Class II device made by Coreline Soft Co., Ltd., cleared under FDA 510(k) K233211 on 29 Mar 2024 and listed in FDA GUDID since 25 Apr 2024 (UDI-DI 08800025300237), 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) K233211

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 Number08800025300237 UDI-DI Date25 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233211 Date29 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233211 decided 29 Mar 2024 Active
  • FDA GUDID UDI-DI 08800025300237 listed 25 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233211
  2. Listed FDA GUDID 08800025300237

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aview Cac
Generic name
Radiological PACS-dedicated management software
Model / reference
1.1
Primary DI / UDI-DI
08800025300237
510(k) Number
FDA product code
QIH, 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)