EAGLESOFT

Primary DI
00350227000193
Brand
EAGLESOFT
Company
PATTERSON TECHNOLOGY CENTER
Model
21.00
Device description
LORIN LIBRARY EAGLESOFT v21.00
Published
2019-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K982422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982422000EAGLESOFT CHAIRSIDEEaglesoft, A Patterson Co.1998-09-30LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00350227000193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350227000193003502270001933502270001930350227000193

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
062232311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350227000520Eaglesoft232023-10-25
00350227300064FUSE1.082020-06-02
00350227300071FUSE1.092020-09-19
00350227000131EAGLESOFT20.102019-02-08
00350227000216FUSE1.032019-01-31
00350227300033FUSE1.052019-07-22
00350227000230EAGLESOFT21.102020-04-10
00350227000247EAGLESOFT21.102020-04-10
00350227000254EAGLESOFT21.102020-04-10
00350227000261EAGLESOFT21.102020-04-10
00350227000278EAGLESOFT21.102020-04-10
00350227000285EAGLESOFT21.102020-04-10
00350227000292EAGLESOFT21.102020-04-10
00350227000308EAGLESOFT21.202020-04-10
00350227000315EAGLESOFT21.202020-04-10
00350227000322EAGLESOFT21.202020-04-10
00350227000339EAGLESOFT21.202020-04-10
00350227000346EAGLESOFT21.202020-04-10
00350227000353EAGLESOFT21.202020-04-10
00350227000360EAGLESOFT21.202020-04-10

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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
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00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
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