Imorgon Medical, LLC

GUDID 00863670000332

imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation 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 report information.

IMORGON MEDICAL LLC

Radiology PACS software

• Primary Device ID: 00863670000332
• NIH Device Record Key: f9d11f24-2bd5-4f29-8519-14b77d31d5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imorgon Medical, LLC
• Version Model Number: Imorgon iSite integrator 14.1
• Company DUNS: 065596356
• Company Name: IMORGON MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net
• Phone: (877)298-7543
• Email: icare@imorgon.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863670000332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050736

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Imorgon Medical, LLC]

• 00863670000349: imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a centr
• 00863670000332: imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a centr
• 00863670000325: imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a centr
• 00863670000318: imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a centr