FDA.report

OptiVu Streamer

Primary DI
07649988969867
Brand
OptiVu Streamer
Company
INCREMED AG
Model
R2.X.Y
Published
2025-04-24
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
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07649988969867PrimaryGS10

GMDN Terms

TermDefinition
Video image processorA mains electricity (AC-powered) device designed to receive the electronic signals sent from a video camera for the purpose of editing and processing them into images. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images will typically be, e.g., a video recording of a magnetic resonance imaging (MRI) examination. Other forms of recording media may be used.

Sterilization Methods

Method

Regulatory Flags

DUNS number
480257180
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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