Skip to content

Iq-Uip 2.1.2

by 4Dmedical Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number19356870000076 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Iq-Uip
Generic Name
Chest/vascular CT/MRI clinical assessment support software
Model / Reference
2.1.2
Primary DI / UDI-DI
19356870000076
510(k) Number
FDA Product Code
QWO
GMDN Term
Chest/vascular CT/MRI clinical assessment support software
Device Class
Class II
Regulation Number
892.2085
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242467)

Other devices from 4Dmedical Limited

See all devices from 4Dmedical Limited →

Properties

  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No