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KEOPS Balance Analyzer 3D

by S.M.A.I.O

510(k) K213975

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 NumberK213975 Date6 May 2022ClearedStatusActive

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The KEOPS Balance Analyzer 3D is a device intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. It allows surgeons and service providers to perform spine-related measurements on images and plan surgical procedures.

The device is supplied by S.M.A.I.O and has received FDA 510(k) clearance with the product code LLZ. It is intended for use in radiology settings and includes tools for surgical planning. The device is not described as single-use or reusable, and no information regarding sterility or MRI safety is provided.

Devices cleared under K213975

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 K213975
UDI-DISize and differences
KBA3D V1.1.X
S.M.A.I.O
V1.1.X03701313000479 —No longer on the market

Similar devices

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

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