VUZE System

510(k) K232976

VUZE System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Vuze Medical Ltd, cleared under FDA 510(k) K232976 on 9 May 2024, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K232976↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK232976	Date9 May 2024Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K232976

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K232976
FDA product code: LLZ
FDA applicant: Vuze Medical , Ltd.

Device class: Class II
Regulation: 21 CFR Part 892.2050
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

Devices cleared under K232976

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232976
		UDI-DI	Size and differences
VUZE System 2.0 VM-PK-001 VUZE MEDICAL LTD	VM-PK-001 / VM-PK-001	07290019776000	—	On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Vuze Medical Ltd

VUZE System 2.0 VM-PK-001

Class II
VUZE System

Class II