LiverMultiScan
GUDID B554LMS2100
LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease. Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
PERSPECTUM DIAGNOSTICS LTD
Radiology DICOM image processing application software| Primary Device ID | B554LMS2100 |
| NIH Device Record Key | ea0bd1ea-4998-4c5d-a46a-98efaaedece5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiverMultiScan |
| Version Model Number | 2.1 |
| Company DUNS | 218593632 |
| Company Name | PERSPECTUM DIAGNOSTICS LTD |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B554LMS2100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172685
FDA Product Code
| LNH | System, Nuclear Magnetic Resonance Imaging |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2018-07-04 |
On-Brand Devices [LiverMultiScan]
| B554LMS2100 | LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to a |
| B554LMS2000 | LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to a |
| B554LMS3100 | LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3 |
| B554LMS3200 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software a |
| B554LMS3300 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software a |
| B554LMS3400 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software a |
Trademark Results [LiverMultiScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIVERMULTISCAN 88601547 not registered Live/Pending |
Perspectum Diagnostics Ltd 2019-09-02 |
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