Imorgon Medical, LLC - imorgon Ultrasound PACS Solutions is a PACS - IMORGON MEDICAL LLC

Duns Number:065596356

Device Description: imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnosticworkstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and reportinformation.

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More Product Details

Catalog Number

-

Brand Name

Imorgon Medical, LLC

Version/Model Number

Imorgon LaunchPad 2.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K050736

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

3cd6f3f8-ba0a-4227-a091-a0f10fb6578f

Public Version Date

May 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMORGON MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5