FDA.reportPublic FDA data

RemotEye Viewer

Primary DI
B383REV090204000
Brand
RemotEye Viewer
Company
NEOLOGICA SRL
Model
9.2.4
Device description
Diagnostic web DICOM viewer
Published
2024-01-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141061000REMOTEYE VIEWERNeologica S.R.L.2014-08-01LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B383REV090204000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39019505314support@neologica.it

Regulatory Flags#

DUNS number
517480120
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B383REV100200000RemotEye Viewer10.2.02025-08-11
B383REV100300000RemotEye Viewer10.3.02026-05-08
B383REV100100000RemotEye Viewer10.1.02025-08-11
B383REV100002000RemotEye Viewer10.0.22024-05-10
B383REV100001000RemotEye Viewer10.0.12024-01-18
B383REV100000000RemotEye Viewer10.0.02024-01-18
B383REV090102000RemotEye Viewer9.1.22016-09-23
B383REV090200000RemotEye Viewer9.2.02017-09-01
B383REV090201000RemotEye Viewer9.2.12017-12-13
B383REV090202000RemotEye Viewer9.2.22018-04-07
B383REV090203000RemotEye Viewer9.2.32018-09-28

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Primary DI, Brand, Company table
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