(27 days)
Not Found
No
The summary describes a standard MR imaging system and does not mention any AI or ML components in the device description, intended use, or image processing.
No.
The device is described as an MR system that produces images for diagnostic purposes, not for therapeutic intervention or treatment.
Yes
The "Intended Use / Indications for Use" section states that "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information," indicating its role in diagnosis.
No
The device description explicitly lists hardware components such as a patient positioning table, magnetic unit, operating console (including PC, keyboard, mouse, monitor), electronics box, and modular shielding box. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, the E-scan Opera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- E-scan Opera's Function: The E-scan Opera is a magnetic resonance (MR) system that produces images of the limbs and joints within the human body. It does not examine specimens outside the body.
- Intended Use: The intended use is to provide diagnostically useful information through the interpretation of MR images by a medical expert. This is a form of in vivo imaging, not in vitro testing.
Therefore, the E-scan Opera falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
E-scan Opera 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the 3. operating table.
-
- Electronics box with filter panel.
- ડ. Modular shielding box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs and joints, including 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
medical expert trained in the use of MR equipment
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 4 2006 510(k) Summary
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: | April 4, 2006 |
807.92(a)(2) | |
Trade Name: | 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 | E-Scan XQ | K032121 |
---|---|---|
Siemens | Magnetom Vision | K945517 |
Esaote | G-Scan | K042236 |
1
807.92(a)(4)
Device Description
Summary of E-scan XQ modifications
The changes performed on the modified E-scan XQ device (E-scan Opera), with respect to the cleared version - E-scan XQ K032121 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
-
- A lower patient table.
-
- A panel with a LCD screen on the front of the magnet.
- Some different external covers due to the patient table lowering and for renewing the equipment 3. aesthetics.
-
- Upgrading of the electronics.
-
- A new software release.
E-scan Opera
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the 3. operating table.
-
- Electronics box with filter panel.
- ડ. Modular shielding box.
2
807.92(a)(5)
Intended Use(s)
E-scan Opera 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 MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice relaxation time (T1), 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)(6)
Technological Characteristics
The modifications to the E-scan XQ system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the system.
3
:
Characteristic | E-scan Opera | E-scan XQ K032121 | Comments |
---|---|---|---|
Patient table: | Maximum load-bearing | ||
capacity = 200 kg (approx. | |||
440 lb) | |||
fixed height (710 cm) | |||
removable from magnet | |||
cavity to facilitate patient | |||
positioning | |||
one section of the bed can | |||
be rotated to enable various | |||
positions in relation to the | |||
region examined (right or | |||
left) | |||
washable covering material | |||
manual positioning | |||
integrated in overall design | |||
of equipment. | Maximum load-bearing | ||
capacity = 200 kg (approx. | |||
440 lb) | |||
fixed height (910 cm) | |||
removable from magnet | |||
cavity to facilitate patient | |||
positioning | |||
one section of the bed can be | |||
rotated to enable various | |||
positions in relation to the | |||
region examined (right or | |||
left) | |||
washable covering material | |||
manual positioning | |||
integrated in overall design | |||
of equipment. | The patient | ||
table of the E- | |||
scan Opera is | |||
20 cm lower | |||
than the | |||
unmodified E- | |||
scan XQ | |||
patient table to | |||
allow a more | |||
easy and | |||
comfortable | |||
patient | |||
positioning | |||
(see Device | |||
Modification | |||
Description | |||
section). |
Characteristic | E-scan Opera | G-scan K042236 | Comments |
---|---|---|---|
Magnetic unit | |||
display panel: | The function of the Display | ||
Panel is displaying real | |||
time sequences for patient | |||
positioning. | |||
Present commands: | The function of the Control | ||
Panel is managing the | |||
movement of the magnet and | |||
of the patient table and | |||
displaying real time | |||
sequences for patient | |||
positioning. | |||
Besides the movement | |||
commands the following | |||
commands are also present: | The E-scan | ||
Opera system, | |||
as the | |||
unmodified E-scan XQ, has | |||
no motorized | |||
movement. So | |||
the function of | |||
the Display | |||
Panel is only | |||
verifying the | |||
correct | |||
centering of the | |||
region being | |||
examined (see | |||
Device | |||
Modification | |||
Description | |||
section). | |||
Preview: begins the real | |||
time sequence and displays | |||
the acquired image on the | |||
LCD panel in the selected | |||
orientation (sagittal, axial, | |||
coronal). | Preview: begins the real time | ||
sequence and displays the | |||
acquired image on the LCD | |||
panel in the selected | |||
orientation (sagittal, axial, | |||
coronal). | |||
Abort: stops the running | |||
sequence. | Abort: stops the running | ||
sequence. |
4
1
ﻪ
,
Characteristic | E-scan Opera | G-scan K042236 | Comments |
---|---|---|---|
Electronics | |||
box and | |||
operating | |||
console: | The signals from the | ||
electronics box to the | |||
operating console pass | |||
through a fiber optic cable. | |||
The operating console is | |||
powered directly by the | |||
mains. | The signals from the | ||
electronics box to the | |||
operating console pass | |||
through a fiber optic cable. | |||
The operating console is | |||
powered directly by the | |||
mains. | See Device | ||
Modification | |||
Description | |||
section. | |||
Electronics | |||
box: | ALDIM unit: supplies the | ||
Display Panel. | ALEL unit: supplies the | ||
Control Panel and the CCE | |||
unit, which drives the | |||
electric motor and activates | |||
the solenoid valves of the | |||
hydraulic circuit. | See Device | ||
Modification | |||
Description | |||
section. | |||
SW version | |||
9.2A: | Reconstruction process on | ||
Host instead of on DSP. | Reconstruction process on | ||
Host instead of on DSP. | See Software | ||
Description | |||
section. |
| Characteristic | E-scan Opera | MAGNETOM Vision
K945517 | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SW version
9.2A: | RF saturation pulses are
used to suppress flow and
motion artifacts. Pre-
saturation regions may be
arbitrarily located in any
orthogonal or oblique
orientation. | RF saturation pulses are
used to suppress flow and
motion artifacts. Pre-
saturation regions may be
arbitrarily located in any
orthogonal or oblique
orientation. | See Software
Description
section. |
| | The Repetition Time (TR)
of each sequence can be
set using fixed step so that
50 or 60 Hz artifacts,
caused by external
magnetic fluctuation, can
be avoided. | Physiologically controlled
imaging: pseudogating is
obtained with a TR
corresponding to the RR
interval in the cardiac
cycle. This application is
used to prevent flow
artifacts (assuming a stable
heart rate). | The same
technique is used
to avoid AC
power line
artifacts (E-scan
Opera) and
motion artifacts
caused by
heartbeat
(MAGNETOM
Vision).
See Software
Description
section. |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter.
MAY 4 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Esaote, S.p.A. % Ms. Carrie Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032
Re: K060956
Trade/Device Name: E-scan Opera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 6, 2006 Received: April 7, 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 Federal 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 circular logo with the text "FDA Centennial 1906-2006" arranged around the perimeter. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are aligned beneath the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
6
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 Compliance at one 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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):
Device Name: E-scan Opera
Indications for Use:
E-scan Opera 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 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.
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)
David R. Lyman
Page 1 of 1
(Division Sian-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number