FDA.report

LumiNE US

Primary DI
08720892617637
Brand
LumiNE US
Company
AugmedIT B.V.
Model
2
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions

SubmissionSupplement
K240094000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240094000LumiNE US; LumiAugmedit B.V.2024-09-10QIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08720892617637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08720892617637087208926176378720892617637

GMDN Terms

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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods

Method

Regulatory Flags

DUNS number
492843148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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