(63 days)
No
The description focuses on standard image processing techniques (time intensity curves, interpolation, slope, asymptotic value) and does not mention AI or ML.
No
The device is described as assisting in diagnosis by providing time intensity curves and images to be interpreted by a physician, not for treating any condition.
Yes
The device is described as providing "time intensity curves that support the diagnostic process" and its output, when "interpreted by a trained physician, yield information that may assist in diagnosis." This directly indicates its use in assisting with diagnosis.
No
The device is described as a "Software Option" intended to be used with existing MRI systems (C-scan, E-scan XQ, E-scan Opera). While it is a software package, its function is directly tied to and dependent on the hardware of the MRI systems for image acquisition. It is not a standalone software device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description clearly states that this software processes MR images acquired directly from the patient's limbs and joints. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device processes imaging data. The core function is the acquisition and processing of MR image datasets to show temporal variations in contrast. This is a form of medical imaging analysis, not in vitro testing.
- The output is imaging-based information. The software provides time intensity curves and related data derived from the MR images, which are then interpreted by a physician. This is distinct from the results of an IVD test, which typically measure specific analytes or markers in a biological sample.
Therefore, this device falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
LNH
Device Description
The Dynamic MRI Software Option is a software package intended to be used with the Esaote C-scan. E-scan XO and E-scan Opera MRI systems, cleared via K040877 K032121 and K060956, respectively, The software package allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired image datasets, showing changes in image contrast over time.
It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value. These data, when interpreted by a trained physician, vield information that may assist diagnosis.
C-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
E-scan XO is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and ioints. It is intended for imaging portions of the arm. including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
The C-scan, E-scan XO and E-scan Opera MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Limbs and joints, specifically:
C-scan: portions of the arm (hand, wrist, forearm, elbow, excluding upper arm) and portions of the leg (foot, ankle, calf, knee, excluding thigh).
E-scan XQ and E-scan Opera: portions of the arm (hand, wrist, forearm, elbow, upper arm, shoulder) and portions of the leg (foot, ankle, calf, knee, thigh, hip).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / medical expert
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
人心儿1429
510(k) Summary C-scan/E-scan XQ/E-scan Opera Esaote S.p.A.
510(k) Summary
JUL 25 2006
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham, Official Correspondent
11460 N. Meridian St., Suite 150
Carmel, IN 46032
| Phone: | (317) 569-9500 x103 |
|---|---|
| Facsimile: | (317) 569-9520 |
| Contact Person: | Carri Graham |
| Date: | May 22, 2006 |
| 807.92(a)(2) | |
| Trade Name: | Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera |
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic Resonance Diagnostic Device |
| Classification Number: | 90LNH |
| 807.92(a)(3) |
Predicate Device(s)
| Esaote | C-scan | K040877 |
|---|---|---|
| Esaote | E-scan XQ | K032121 |
| Esaote | E-scan Opera | K060956 |
| Siemens Medical Systems | Perfusion Package for Magnetom Vision and Symphony MR Systems | K984224 |
| GE Medical Systems | Advantage Windows with FuncTool Option | K960265 |
1
807.92(a)(4)
Device Description
The Dynamic MRJ Software Option is a software package intended to be used with the Esaote C-scan. E-scan XO and E-scan Opera MRI systems, cleared via K040877 K032121 and K060956, respectively, The software package allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired image datasets, showing changes in image contrast over time.
It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value. These data, when interpreted by a trained physician, vield information that may assist diagnosis.
C-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
E-scan XO is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and ioints. It is intended for imaging portions of the arm. including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
The C-scan, E-scan XO and E-scan Opera MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
807.92(a)(5)
Intended Use(s)
The Dynamic MRI Software Option for the C-scan, E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, vield information that may assist in diagnosis.
2
807.92(a)(6)
Technological Characteristics
The addition of the Dynamic MRI Software Option, reflected in this 510(k), does not alter the fundamental scientific technology of the C-scan system, cleared via K040877, E-scan XQ system, cleared via K032121 and E-scan Opera system, cleared via K060956.
| Characteristic | Dynamic MRI
Software Option
for C-scan, E-scan
XQ and E-scan
Opera | C-scan
K040877 | E-scan XQ
K032121 | E-scan Opera
K990968 | Comments |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse sequences | Spin Echo T1
(SETI)
Gradient Echo (GE) | Spin Echo T1
(SETI)
Gradient Echo (GE) | Spin Echo T1
(SETI)
Gradient Echo (GE) | Spin Echo T1
(SETI)
Gradient Echo (GE) | Unchanged |
| Sequence
parameters | Spin Echo 16
TR from 40 ms to
5000 ms, step 20 ms
TE fixed at 16 ms
minimum FOV 100
mm
minimum slice
thickness 2 mm | SETI
TR from 40 ms to
5000 ms, step 20 ms
TE from 18 ms to 34
ms, step 2 ms
minimum FOV 100
mm
minimum slice
thickness 2 mm | SET 1
TR from 50 ms to
5000 ms, step 10 ms
TE from 18 ms to 34
ms, step 2 ms
minimum FOV 100
mm
minimum slice
thickness 2 mm | SETI
TR from 50 ms to
5000 ms, step 10 ms
TE from 18 ms to 34
ms, step 2 ms
minimum FOV 100
mm
minimum slice
thickness 2 mm | They are a
particular
version of the
Spin Echo T1
and Gradient
Echo standard
sequences for
obtaining high
acquisition
speed and
contrast
resolution. |
| | Gradient Echo 6
TR from 40 ms to
5000 ms, step 20 ms
TE fixed at 6 ms
FA from 10° to 90°,
step 5°
minimum FOV 100
mm
minimum slice
thickness 2 mm | GE
TR from 40 ms to
5000 ms, step 20 ms
TE from 8 ms to 24
ms, step 2 ms
FA from 10° to 90°,
step 5°
minimum FOV 100
mm
minimum slice
thickness 2 mm | GE 10
TR from 35 ms to
5000 ms, step 5 ms
TE fixed at 10 ms
FA from 10° to 90°,
step 5°
minimum FOV 130
mm
minimum slice
thickness 2 mm | GE 10
TR from 35 ms to
5000 ms, step 5 ms
TE fixed at 10 ms
FA from 10° to 90°,
step 5°
minimum FOV 130
mm
minimum slice
thickness 2 mm | |
Substantial Equivalence Comparison Tables
3
| Characteristic | Dynamic MRI Software Option for C-scan, E-
scan XQ and E-scan Opera | Perfusion package for Magnetom Vision and
Symphony MR systems - K984224 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | LNH | LNH |
| Indications for use | The Dynamic MRI Software Option for the C-scan,
E-scan XQ and E-scan Opera MRI Systems allows
the acquisition of MR dynamic image datasets and
the post processing display of temporal variations
in the acquired datasets, showing changes in
contrast over time. Its purpose is to provide time
intensity curves that support the diagnostic process.
These images when interpreted by a trained
physician, yield information that may assist in
diagnosis. | The Perfusion Package for the Magnetom Vision
and Symphony MR Systems is a software
package which allows the display of temporal
variations in dynamic MR Datasets, showing
changes in contrast over time. Its purpose is to
provide either time intensity curves or the
creation of parametric images for parameters like
time to peak that support the diagnostic process.
These images when interpreted by a trained
physician, yield information that may assist in
diagnosis. One clinical application where this
could be useful is the diagnosis of lesions by
temporal analysis of tumor enhancement. |
| Device
Description | The Dynamic MRI Software Option is intended to
acquire MR dynamic image datasets and uses a
post processing procedure for display of temporal
variations in the acquired datasets for the C-scan,
E-scan XQ and E-scan Opera MRI Systems. | The Perfusion Package is a post processing
option for the Magnetom Vision and Symphony
MR Systems |
| Technological
Characteristics | The magnet, RF system and gradient system of C-
scan, E-scan XQ and E-scan Opera MRI Systems
configured with the Dynamic MRI Software
Option is substantially equivalent to the standard
C-scan, E-scan XQ and E-scan Opera Systems. | The magnet, RF system and gradient system of
the Magnetom Vision and Symphony configured
with the Perfusion Package is substantially
equivalent to the standard Magnetom Vision and
Symphony Systems. |
| Input data | Dynamic MR datasets
Single or multi-slice datasets | Dynamic MR datasets |
| Features | Display of temporal variations in dynamic MR
datasets, showing changes in image contrast over
time | Display of temporal variations in dynamic MR
datasets, showing changes in image contrast over
time |
| Image Processing | Time intensity data and time intensity interpolation
curve, its maximum slope and its asymptotic value | Time intensity curves
Parametric images for parameters like time to
peak |
:
:
:
.
4
·
| Characteristic | Dynamic MRI Software Option for
C-scan, E-scan XQ and E-scan Opera | FuncTool Option
K960265 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | LNH | LLZ |
| Indications for use | The Dynamic MRI Software Option for the
C-scan, E-scan XQ and E-scan Opera MRI
Systems allows the acquisition of MR
dynamic image datasets and the post
processing display of temporal variations in
the acquired datasets, showing changes in
contrast over time. Its purpose is to provide
time intensity curves that support the
diagnostic process. These images when
interpreted by a trained physician, yield
information that may assist in diagnosis. | The FuncTool option to the Advantages Windows
workstation is a software module that provides
supplemental information to those images extracted
from CT and MR temporal datasets. |
| Device
Description | The Dynamic MRI Software Option is
intended to acquire MR dynamic image
datasets and uses a post processing procedure
for display of temporal variations in the
acquired datasets for the C-scan, E-scan XQ
and E-scan Opera MRI Systems. | FuncTool is a functional imaging software package,
which allows to display the temporal variation in
dynamic CT and MR datasets. Single or multi-slice
datasets, with equally spaced time interval are used for
input. The purpose is to provide Time Intensity Curves
and parametric images that provide clinical information
for diagnosis purposes. This software is used during
post-processing of MR and CT images on GE's CT and
MR Systems. |
| Input data | Dynamic MR datasets
Single or multi-slice datasets with equally or
differently spaced time interval | Dynamic CT and MR datasets
Single or multi-slice datasets, with equally spaced time
interval |
| Features | Display of temporal variations in dynamic
MR datasets, showing changes in image
contrast over time | Display of temporal variations in dynamic CT and MR
datasets, showing changes in image contrast over time |
| Image Processing | Time intensity data and time intensity
interpolation curve, its maximum slope and
its asymptotic value | Time intensity curves and parametric images |
:
.
. :
.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized lines that resemble a person embracing another person, representing the department's mission of providing essential human services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
Esaote, S.p.A. % Ms. Carri Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032
Re: K061429
Trade/Device Name: Dynamic MRI Software for C-scan, XQ and E-scan Opera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 22, 2006 Received: May 23, 2006
Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual 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 Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Eederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/5/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary of the FDA from 1906-2006. The letters "FDA" are in a bold, sans-serif font in the center of the circle. The word "Centennial" is written in a cursive font below the letters "FDA". Three stars are centered below the word "Centennial".
noting Public G
6
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Conipliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): Kol /429
Device Name: Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera
Indications for Use:
The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Nancy C. Mendoza
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number