FDA.report

CuratOR

Primary DI
04995047068570
Brand
CuratOR
Company
EIZO CORPORATION
Model
MIR-1
Catalog number
MIR-1
Device description
4K Medical Imaging Recorder
Published
2024-08-29
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
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04995047068570PrimaryGS10

GMDN Terms

TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-900-8383support@eizo.com

Regulatory Flags

DUNS number
691033005
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

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04995047070542RadiForce®MX243WMX243W-GHBK2025-09-12
04995047060567RadiForce®GX570GX570-BK2025-09-08
04995047060611RadiForce®GX570GX570-BK-MD2025-09-08
04995047060666RadiForce®GX570GX570-ARBK2025-09-08
14995047060724RadiForce®GX570GX570-ARBK-MD2025-09-08
04995047060758RadiForce®GX570GX570-BK-P2025-09-08
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04995047070320CuratOREX3220EX3220-WT2025-07-18
04995047052814RadiForce®MX194MX194-SIBK2025-07-11
04995047064404RadiForce®RX370RX370-SIBK2025-07-11
04995047065661RadiForce®MX243WMX243W-SIBK2025-07-11
04995047067849RadiForce®MX217MX217-SIBK2025-07-11
14995047068256RadiForce®RX570RX570-BK-MD2025-07-11
04995047069959CuratOREX3220-3DEX3220-3D-WT2025-05-01
04995047069997NAEX3220-3D, PV648EX3220-3D-AE2025-04-25
14995047068041RadiForce®RX570RX570-BK-MD2024-12-05
04995047068167RadiForce®RX570RX570-ARBK2024-12-05
04995047068242RadiForce®RX570RX570-BK2024-12-05
14995047068348RadiForce®RX570RX570-ARBK-MD2024-12-05
04995047067740RadiCSVer.5.2.xRadiCS2024-11-08

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