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Iq-Uip

by Imbio, Inc.

510(k) K242467

Iq-Uip is a Class II device made by Imbio, Inc., cleared under FDA 510(k) K242467 on 19 Dec 2024, active as of 10 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 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242467 Date19 Dec 2024ClearedStatusActive

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  • Withdrawn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
QWO
Device class
Class II
Regulation
21 CFR Part 892.2085
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K242467

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 K242467
UDI-DISize and differences
IQ-UIP 2.0.0
4DMEDICAL LIMITED
2.0.000850894007919 —On the market
IQ-UIP 2.1.2
4DMEDICAL LIMITED
2.1.219356870000076 —On the market

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