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icobrain aria 1.2

by icometrix NV

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 NumberB621ICOBRAINARIA1X2Y0 UDI-DI Date24 Oct 2025ListedStatusListed 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  • Withdrawn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
icobrain aria
Generic Name
Radiology DICOM image processing application software
Model / Reference
1.2
Primary DI / UDI-DI
B621ICOBRAINARIA1X2Y0
510(k) Number
FDA Product Code
QBS
GMDN Term
Radiology DICOM image processing application software
Device Class
Class II
Regulation Number
892.2090
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K240712)

Other devices from icometrix NV

See all devices from icometrix NV →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No