Skip to content

CubeVue

by CurveBeam LLC

510(k) K181962

CubeVue is a Class II device made by CurveBeam LLC, cleared under FDA 510(k) K181962 on 7 Aug 2018, 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

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181962 Date7 Aug 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
FDA applicant
Curvebeam, LLC
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K181962

2 devices · 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 K181962
UDI-DISize and differences
CubeVue 3.6.0
CurveBeam LLC
3.6.000863152000362 —On the market
CubeVue 3.7.0
CurveBeam LLC
3.7.000863152000379 —On the market

Similar devices

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

Other devices from CurveBeam LLC

  • Ossview

    Class IIa

  • PedCAT 1000-230

    Class II

  • PedCAT 1000-115

    Class II

  • CubeVue 3.6.0

    Class II

See all devices from CurveBeam LLC →