Skip to content

Aid-U

by Iaid

510(k) K231662

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231662 Date8 Feb 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Overview

AI-generated summary, 25 Sep 2026

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

Aid-U is a Class II X-ray system used in radiology. It is substantially equivalent to a predicate device.

It is supplied by Iaid and has received FDA 510(k) clearance under K-number K231662. The device is manufactured in Seoul, South Korea.

Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Aid-U device used for?

    The Aid-U is a Class II X-ray system used in radiology for imaging purposes, as indicated by its product code LLZ and advisory committee classification under radiology.

  • How is the Aid-U supplied and by whom?

    The Aid-U is supplied by its manufacturer, Iaid, and is produced in Seoul, South Korea, as stated in the device’s authorization and manufacturing details.

  • What regulatory clearance does the Aid-U have?

    The Aid-U has received FDA 510(k) clearance under K-number K231662, with a traditional clearance type and a decision of substantially equivalent (SESE) granted on February 8, 2024.