nCommand Lite System

Primary DI
07898974112002
Brand
nCommand Lite System
Company
IONIC HEALTH TECHNOLOGIES S/A
Model
Software version
Device description
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a webapplication for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensedtechnologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing systemCT scanner.Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimumrequired specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. Thisallows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to localregulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at anytime by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session iscontrolled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session ata 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 toview multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as onlyone keyboard and one mouse are provided.Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parametermanagement and remote scanning.
Published
2024-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K233660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233660000nCommand Lite SystemIonic Health2024-03-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898974112002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898974112002078989741120027898974112002

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
925763314
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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