FDA.reportPublic FDA data

EAGLESOFT

Primary DI
00350227000285
Brand
EAGLESOFT
Company
PATTERSON TECHNOLOGY CENTER
Model
21.10
Device description
LORIN LIBRARY EAGLESOFT v21.10
Published
2020-04-10
Public version status
Update
Distribution status
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
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
00350227000285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350227000285003502270002853502270002850350227000285

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(818) 435-1846susan.kado@pattersoncompanies.com

Regulatory Flags#

DUNS number
062232311
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350227000520Eaglesoft 232023-10-25
00350227000131EAGLESOFT20.102019-02-08
00350227000230EAGLESOFT21.102020-04-10
00350227000247EAGLESOFT21.102020-04-10
00350227000254EAGLESOFT21.102020-04-10
00350227000261EAGLESOFT21.102020-04-10
00350227000278EAGLESOFT21.102020-04-10
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
00350227000162EAGLESOFT21.002019-10-25
00350227000179EAGLESOFT21.002019-10-25
00350227000186EAGLESOFT21.002019-10-25
00350227000193EAGLESOFT21.002019-10-25
00350227000209EAGLESOFT21.002019-10-25

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Primary DI, Brand, Company table
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