DEVICE: nCommand Lite System (07898974112002)
Device Identifier (DI) Information
nCommand Lite System
Software version
In Commercial Distribution
IONIC HEALTH TECHNOLOGIES S/A
Software version
In Commercial Distribution
IONIC HEALTH TECHNOLOGIES S/A
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web
application for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed
technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing system
CT scanner.
Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum
required specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. This
allows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to local
regulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at any
time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is
controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at
a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use.
nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to
view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only
one keyboard and one mouse are provided.
Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter
management and remote scanning.
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? |
---|---|---|---|---|
57812 | Radiology DICOM image processing application software |
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K233660 | 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
0cc93833-4946-433f-91f0-9cf96a1dc9df
December 03, 2024
2
July 15, 2024
December 03, 2024
2
July 15, 2024
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined