FDA.reportPublic FDA data

icompanion

Primary DI
B621ICOMPANION103
Brand
icompanion
Company
icometrix NV
Model
1
Published
2023-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
NXQReminder, Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
NXQReminder, MedicationPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161148000icobrainIcometrix2016-08-09LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B621ICOMPANION103PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400793486
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B621ICOBRAINARIA1X2Y0icobrain aria1.22025-10-24
B621ICOBRAINMR5X17Y0icobrain mr5.172025-09-19
B621ICOBRAINARIA1X1Y0icobrain aria1.12025-02-18
B621ICOBRAINCT6X4Y0icobrain ct6.42024-10-11
B621ICOBRAINMR5X16Y0icobrain mr5.162024-08-06
B621ICOMPANION2X2Y0icompanion2.22024-06-07
B621ICOBRAINMR5X15Y0icobrain mr5.152024-05-29
B621ICOMPANION2X1Y0icompanion2.12024-02-08
B621ICOBRAINMR5X14Y0icobrain mr5.142023-12-08
B621ICOBRAIN60icobrain62022-06-24
B621ICOBRAINCTP10icobrain ctp12022-06-24
B621ICOBRAIN50icobrain52020-02-17
B621ICOBRAIN40icobrain4.02019-04-08
B621ICOBRAIN20icobrain22018-01-29
B621ICOBRAIN30icobrain32018-03-19

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