CT LVAS 1.x

by 4DMEDICAL Limited

CT LVAS 1.x is a Class II device made by 4DMEDICAL Limited, cleared under FDA 510(k) K232392 on 16 Nov 2023 and listed in FDA GUDID since 20 Jun 2024 (UDI-DI 19356870000021), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number19356870000021 UDI-DI	Date20 Jun 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232392	Date16 Nov 2023Decided	StatusActive

Official records

AccessGUDID record UDI-DI 19356870000021
FDA 510(k) database 510(k) number K232392

Across registries

2 registries list this device

FDA 510(k) K232392 decided 16 Nov 2023 Active
FDA GUDID UDI-DI 19356870000021 listed 20 Jun 2024 Listed

Timeline

2 dated events

16 Nov 2023 Cleared FDA 510(k) K232392
20 Jun 2024 Listed FDA GUDID 19356870000021

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CT Lvas
Generic name: CT system application software
Model / reference: 1.x

Primary DI / UDI-DI: 19356870000021
510(k) Number: K232392
FDA product code: JAK
GMDN term: CT system application software

Device class: Class II
Regulation number: 892.1750
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under CT system application software.

Other devices from 4DMEDICAL Limited

LTA Software

Class IIa
Pha 4.0.1

Class II
Iq-Uip 2.1.2

Class II
LDA 5.2.x

Class II

See all devices from 4DMEDICAL Limited →

Properties

Prescription use

Other properties (14, all answered No)