FDA.reportPublic FDA data

Change Healthcare Radiology Solutions

Primary DI
17540262030068
Brand
Change Healthcare Radiology Solutions
Company
Change Healthcare Canada Company
Model
14.2.2
Published
2025-05-16
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
K140909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140909000MCKESSON RADIOLOGYMckesson Medical Imaging Company2014-07-02LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540262030068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026203006817540262030068

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
246576391
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540262200102Change Healthcare Stratus Imaging Diagnostic Viewer2.102026-07-22
17540262200096Change Healthcare Stratus Imaging Diagnostic Viewer2.92026-05-27
17540262020014McKesson Radiology12.32018-02-20
17540262140262Change Healthcare Stratus Imaging Viewer1.0.252026-04-16
17540262200010Stratus Imaging Diagnostic Viewer2.12025-10-27
17540262200034Change Healthcare Stratus Imaging Diagnostic Viewer2.32025-10-27
17540262140255Change Healthcare Stratus Imaging Viewer1.0.242026-03-19
17540262140248Change Healthcare Stratus Imaging Viewer1.0.232026-01-29
17540262140231Change Healthcare Stratus Imaging Viewer1.0.222025-11-20
17540262160185Change Healthcare Stratus Imaging PACS1.7.02025-09-15
17540262160161Change Healthcare Stratus Imaging PACS1.4.72024-12-10
17540262130225Change Healthcare Stratus Imaging Viewer1.0.212025-08-05
17540262010060Change Healthcare Enterprise Viewer14.2.12025-06-26
17540262130218Change Healthcare Stratus Imaging Viewer1.0.202025-06-23
17540262180053Change Healthcare Mammography Plus14.2.22025-05-16
17540262130201Change Healthcare Stratus Imaging Viewer1.0.192025-04-03
17540262160178Change Healthcare Stratus Imaging PACS1.4.82025-04-03
17540262130195Change Healthcare Stratus Imaging Viewer1.0.182024-08-21
17540262160147Change Healthcare Stratus Imaging PACS1.4.62024-06-28
17540262130188Change Healthcare Stratus Imaging Viewer1.0.172024-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01
00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17