(56 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard image processing and data visualization techniques for MRI data.
No
The device is described as an "accessory diagnostic device" used for the "determination of iron in the liver," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The R2-MRI Analysis System is an accessory diagnostic device".
Yes
The device description explicitly states it is a "Software tool" and acts as an "accessory" to an MR scanning machine, focusing on data import, visualization, and analysis of existing MRI data. There is no mention of hardware components being part of the device itself.
Based on the provided information, the R2-MRI Analysis System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "accessory diagnostic device... for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver." This clearly indicates a diagnostic purpose.
- Device Description: The description further clarifies its role in providing "objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status." This is a diagnostic assessment.
- Anatomical Site: It focuses on the liver, which is an internal organ, and the analysis is performed on data derived from the patient's body.
- Input Imaging Modality: It uses Magnetic Resonance data, which is a common modality for obtaining diagnostic information from within the body.
While the device processes data from an MRI machine (which is an in vivo imaging device), the analysis and determination of liver iron status based on that data falls under the scope of in vitro diagnostics, as it's a diagnostic test performed on a sample (the MRI data representing the liver) to provide diagnostic information.
The fact that it's an "accessory diagnostic device" further supports its classification as an IVD, as it's designed to be used in conjunction with other diagnostic equipment to provide a diagnostic result.
N/A
Intended Use / Indications for Use
For the analysis of multi-slice, spin-echo MRI data sets of the liver for the measurement of liver R2 and liver iron concentration.
The R2-MRI Analysis System is an accessory diagnostic device to the Magnetic Resonance Imaging for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Product codes
LNH
Device Description
Software tool used as an accessory to an MR scanning machine, to facilitate the import and visualization of data sets encompassing the multi-slice, spin-echo MRI abdomen, with functionality independent of the MRI equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Liver (abdomen)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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K04327/
510(k) Submission: R2-MRI Analysis System
JAN 2 1 2005
Inner Vision Biometrics Pty Ltd
510(K) SUMMARY 3.
| SUBMITTED BY: | Inner Vision Biometrics Pty Ltd |
|---|---|
| 216 Stirling Highway | |
| Claremont WA 6010 | |
| Australia | |
| Contact in Australia: | Dr Janet Preuss |
| Quality Assurance and Regulatory Affairs Manager | |
| Tel: +61 8 9286 5307 | |
| Fax: +61 8 9286 5399 | |
| Contact in the US: | Mr Greg Holland |
| Regulatory Specialists Inc. | |
| 3722 Ave. Sausalito | |
| Irvine, CA 92606 | |
| Tel: 949-262-0411 | |
| Fax: 949 552 2821 | |
| DATE: | November 24 2004 |
| NAME OF DEVICE: | R2-MRI Analysis System |
| Classification Name: | System, Image Processing |
| Classification Number: | 892.1000 |
| Trade/Proprietary Name: | R-MRI Analysis System |
1
Image /page/1/Picture/1 description: The image shows a handwritten note with the word "KOBZZZI" on the top line. The second line contains the text "June 2024". The handwriting is somewhat cursive and slightly difficult to read.
Medis, MRI (Magnetic resonance Analytical PREDICATE DEVICE(S): K994283: Software System) Resonance Diagnostic KARI ARA
Magnetic Hitachi. Device Version 6 Operating System Software
Software tool used as an accessory to an MR scanning DEVICE DESCRIPTION: facilitate the import and visualization of machine, to data sets encompassing the multi-slice, spin-echo MRI independent of the MRI abdomen, with functionality equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.
- The operational principle of the R2-MRI Analysis System is Scientific Concepts: based on fitting signal decay curves to the image signal intensities (e.g. of the liver) at the different echo times for the MR data set on a voxel-by-voxel (3-D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo.
- For the analysis of multi-slice, spin-echo MRI data sets of the INTENDED USE: liver for the measurement of liver R2 and liver iron concentration.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The device has been shown to substantially equivalent to the Medis MRI (Magnetic resonance Analytical Software System) and the Hitachi, Magnetic Resonance Diagnostic Device Version 6 Operating System Software:
| | R2-MRI Analysis
System | Medis, MRI (Magnetic
resonance Analytical
Software System) | Hitachi, Magnetic
Resonance Diagnostic
Device Version 6
Operating System
Software |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | II | II | II |
| 510(k) number | N/A | K994283 | K961969 |
| Classification Name | System, Nuclear
Magnetic Resonance
Imaging, System, Image
Processing Radiological | System, Image
Processing | System, Nuclear
Magnetic Resonance
Imaging |
| CFR Section | 892.1000 | 892.1000 | 892.1000 |
| Product Code and
Classification Panel | LNH | LNH | LNH |
| | R2-MRI Analysis
System | Medis, MRI (Magnetic
resonance Analytical
Software System) | Hitachi, Magnetic
Resonance Diagnostic
Device Version 6
Operating System
Software |
| Device Name | R2-MRI Analysis
System | MRI-Magnetic
Resonance Analytical
Software System | Magnetic Resonance
Diagnostic Device |
| Trade/Common Name | R2-MRI Analysis
System | MASS (Magnetic
resonance Analytical
Software System) | Version 6 Operating
System Software |
| Description | Software tool to
facilitate the import and
visualization of
multi-slice, spin-echo
MRI data sets
encompassing the
abdomen, with
functionality
independent of the MRI
equipment vendor, to
provide objective and
reproducible
determination of liver
parameters to support
clinicians in the
assessment of liver iron
status. | Software tool to
facilitate the import and
visualization of
multi-slice, multi-phase
MRI data sets
encompassing the
cardiac chambers, with
functionality
independent of the MRI
equipment vendor, to
provide objective and
reproducible
determination of cardiac
parameters to support
clinicians in the
assessment of heart
function. | Revisions of a software
operating system for
MR scanners that
"include the addition of
RF spoiling, SSP for
enhanced 3D MRA, RF
Fat Suppression, MTC
for background
suppression, 3D-FSE,
3D-FIR, rephrase added
to 2D-FSE and 2D-GFE,
2D-FIR Dual Contrast,
RF coil uniformity
image post-processing,
and adaptive image
post-processing" where
"images may be
produced in which the
contrast is primarily
dependent on T1
relaxation, T2 relaxation,
proton density , or a
combination of all three. |
| Intended use | For the objective and
reproducible analysis of
multi-slice, spin-echo
MR data sets of the liver
for the measurement of
liver R2 and liver iron
concentration. | For the objective and
reproducible analysis of
multi-slice, multi-phase
left and right ventricular
function from cardiac
MR data sets. | "... intended to provide
the physician with
physiological and
clinical information,
obtained non-invasively
and without the use of
ionizing radiation" of
"... cross-sectional
images that display the
internal structure of the
head, body, or
extremities". |
| Intended purpose(s) | 1. Supporting clinical
diagnoses about the
status of liver iron
concentration.
2. Supporting the | "1. Supporting clinical
diagnoses about the
status of the global and
regional function and
anatomy of the cardiac
chambers. | "Intended to provide the
physician with
physiological and
clinical information,
obtained non-
invasively." "When |
| | R2-MRI Analysis
System | Medis, MRI (Magnetic
resonance Analytical
Software System) | Hitachi, Magnetic
Resonance Diagnostic
Device Version 6
Operating System
Software |
| | decision-making
processes.
3. Supporting the use
in clinical research
trials, directed at
studying changes in
liver iron concentration
as a result of
interventions. | 2. Supporting the
subsequent clinical
decision-making
processes.
3. Supporting the use
in clinical research
trials, directed at
studying changes in
function and anatomy of
the heart chambers as a
result of interventions." | interpreted by a trained
physician, these images
provide information that
can be useful in
diagnosis
determination."
"Diagnostic uses"
include "T1, T2, proton
density measurements". |
| Image-type utilized | Magnetic Resonance | Magnetic Resonance | Magnetic Resonance |
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Image /page/3/Picture/1 description: The image contains handwritten text that appears to be a combination of numbers and letters. The text includes "K04-327" on the top line, followed by what looks like "Page 4 of 4" on the bottom. The handwriting is somewhat unclear, making it difficult to discern the exact characters and their arrangement.
=
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Inner Vision Biometrics Pty Ltd. % Mr. Greg Holland Regulatory Consultant 3722 Ave. Sausalito IRVINE CA 92606
Re: K043271
Trade/Device Name: R2-MRI Analysis System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 24, 2004 Received: November 26, 2004
Dear Mr. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leveleved your becared by equivalent (for the indications for use stated in above and have deteninmed the at predicate devices marketed in interstate commerce prior to the cliciosure) to regally markets president Device Amendments, or to devices that have been May 26, 1770, the clacinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the proval application (PMA). You may, therefore, market the do not require approval on a premanes approvisions of the Act. The general controls provisions of the Act device, subject to the general volual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your device is classinod (300 as 10) and controls. Existing major regulations affecting your Apploval), it may be sabject to addreaderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can oc round in moncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that F Case of advised that + Dr. I on that your device complies with other requirements of the Act or any For has made a decemination and mistered by other Federal agencies. You must comply with all the I car statues and regulations as and limited to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) This fetter will anow you to begin manuting of substantial equivalence of your device to a legally premarket nothication. The I DA midnig of bassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your correct of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entires) formation on your responsibilities under the Act from the 807.97). Tou may obtain other general and Consumer Assistance at its toll-free number (800) DVISION of 311an Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. È rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT 2.
510(k) Number (if known): Ko 4 327/
R2-MRI Analysis System Device Name:
The R2-MRI Analysis System is an accessory diagnostic device to Indications For Use: The R. Nr. International for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Nancy C. Brogdon
Olvision Sign-Off) ivision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Inner Vision Biometrics Pty Ltd
Confidential
Page 10