G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004

Q: Who is the manufacturer of G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004?

Esaote, S.p.A. filed the 510(k) submission for G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 (K060956).

Q: What is the FDA product code for G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004?

E-scan XQ (K032121); Magnetom Vision (K945517); G-Scan (K042236).

Q: Who can help prepare an FDA 510(k) submission like G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K060956 · Esaote, S.p.A. · LNH · May 4, 2006 · Radiology

Device Facts

Record ID	K060956
Device Name	G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
Applicant	Esaote, S.p.A.
Product Code	LNH · Radiology
Decision Date	May 4, 2006
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2

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.

Device Story

E-scan Opera is a modified magnetic resonance imaging (MRI) system for limb and joint diagnostics. Input: magnetic resonance signals from hydrogen nuclei in patient anatomy. Operation: system generates cross-sectional images (transversal, sagittal, coronal, oblique) based on T1, T2, nuclei density, flow velocity, and chemical shift parameters. Modifications from predicate (E-scan XQ) include lower patient table, LCD display panel on magnet, updated electronics, and new software release. Used in clinical settings by trained medical experts to interpret images for diagnostic purposes. Output: visual MR images displayed on console/LCD panel. Benefits: improved patient positioning via lower table; enhanced system performance through electronics/software upgrades.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of system modifications.

Technological Characteristics

Magnetic resonance diagnostic device. Components: patient positioning table (200kg capacity), magnetic unit with LCD display, PC-based operating console, electronics box, modular shielding. Connectivity: fiber optic signal transmission. Software: version 9.2A, reconstruction process moved from DSP to Host. Imaging parameters: T1, T2, proton density, flow velocity, chemical shift. RF saturation pulses used for artifact suppression. Fixed TR steps to mitigate 50/60 Hz power line interference.

Indications for Use

Indicated for MR imaging of human limbs and joints, including arm (hand, wrist, forearm, elbow, upper arm, shoulder) and leg (foot, ankle, calf, knee, thigh, hip). For use by medical experts trained in MR equipment.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

E-scan XQ (K032121)
Magnetom Vision (K945517)
G-Scan (K042236)

Submission Summary (Full Text)

{0}------------------------------------------------ K060956 # 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: - 1. A lower patient table. - 2. 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. - 4. Upgrading of the electronics. - 5. A new software release. #### E-scan Opera The system is composed of these main parts: - 1. Patient positioning table. - 2. 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. - 4. 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

G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004

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G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004

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Indications for Use

Device Story

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Special Controls

Predicate Devices

Submission Summary (Full Text)

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