FDA.report

interWORKS

Primary DI
00850054590145
Brand
interWORKS
Company
Avreo Inc
Model
Version 8.9.0.21572
Published
2025-11-14
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
00850054590145PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
175766216
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850054590152interWORKSVersion 8.5.0.215892025-12-08
00850054590138interWORKSVersion 8.6.0.214812025-08-26
00850054590121interWORKSVersion 8.8.0.213492025-04-22
00850054590114interWORKSVersion 8.7.0.211262025-02-04
00850054590107interWORKSVersion 8.7.0.211762025-01-27
00850054590091interWORKSVersion 8.7.0.210822024-11-11
00850054590084interWORKSVersion 8.6.0.210402024-09-18
00850054590077interWORKSVersion 8.6.0.209922024-07-09
00850054590060interWORKSVersion 8.6.0.209172024-05-21
00850054590053interWORKSVersion 8.6.0.208602024-04-05
00850054590046interWORKS8.6.0.208242024-03-11
00850054590039interWORKS8.5.0.205302023-09-19
00850054590022interWORKS8.5.205302023-08-23
00850054590015interWORKS8.5.203562023-07-10

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04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01
00612479273597McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277359McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277366McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00850061871268IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850025268332Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-05-16
07649988969867OptiVu StreamerINCREMED AGLMD2025-04-24
00850054590121interWORKSAvreo IncLMD2025-04-22
00300021451554Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
05415334053717BarcoBarco NVLMD2025-04-14
05415334053724BarcoBarco NVLMD2025-04-14
05415334053731BarcoBarco NVLMD2025-04-14
05415334054059BarcoBarco NVLMD2025-04-14
00628105001182Vitrea ReadCanon Medical Informatics A/SLMD2025-04-04