DEVICE: DELTAmanager (00861333000309)
Device Identifier (DI) Information
DELTAmanager
12
In Commercial Distribution
MEDIMAGE, INC.
12
In Commercial Distribution
MEDIMAGE, INC.
DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60724 | Multidisciplinary medical image management software |
A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPS | System, Tomography, Computed, Emission |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K933321 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
825eb7e9-a8bb-42f7-a277-a830902dc838
January 10, 2023
5
September 14, 2016
January 10, 2023
5
September 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
734-665-5400
sales@medimage.com
sales@medimage.com