icobrain 6

by icometrix NV

icobrain 6 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, cleared under FDA 510(k) K192130 on 13 Dec 2019 (3 earlier submissions) and listed in FDA GUDID since 24 Jun 2022 (UDI-DI B621ICOBRAIN60), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

+3 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB621ICOBRAIN60 UDI-DI	Date24 Jun 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK192130	Date13 Dec 2019Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK181939	Date6 Nov 2018Decided	StatusActive
United States	FDA 510(k) from GUDID	NumberK180326	Date8 Mar 2018Issued	StatusActive
United States	FDA 510(k) from GUDID	NumberK161148	Date9 Aug 2016Issued	StatusActive

Official records

FDA 510(k) database 510(k) number K192130
FDA 510(k) database 510(k) number K181939
FDA 510(k) database 510(k) number K180326
FDA 510(k) database 510(k) number K161148

Across registries

2 registries list this device

FDA 510(k) K192130 decided 13 Dec 2019 Active· +3 more in the status table
FDA GUDID UDI-DI B621ICOBRAIN60 listed 24 Jun 2022 Listed

Timeline

5 dated events

9 Aug 2016 Cleared FDA 510(k) K161148
8 Mar 2018 Cleared FDA 510(k) K180326
6 Nov 2018 Cleared FDA 510(k) K181939
13 Dec 2019 Cleared FDA 510(k) K192130
24 Jun 2022 Listed FDA GUDID B621ICOBRAIN60

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: icobrain
Generic name: Radiology DICOM image processing application software
Model / reference: 6

Primary DI / UDI-DI: B621ICOBRAIN60
510(k) Number: K161148
K180326
K181939
K192130
FDA product code: LLZ
GMDN term: Radiology DICOM image processing application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Other properties (15, all answered No)