Who is the manufacturer of G-SCAN?

Esaote, S.p.A. filed the 510(k) submission for G-SCAN (K042236).

What is the FDA product code for G-SCAN?

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

What is the regulatory pathway for G-SCAN?

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

What are the predicate devices for G-SCAN?

E-scan XQ (K032121); AIRIS II (K001334); MAGNA SL (K940894); Magna 5000 Phased Array CTL Spine Coil (K994345); UROLOGIC (K011311).

Who can help prepare an FDA 510(k) submission like G-SCAN?

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.

G-SCAN

K042236 · Esaote, S.p.A. · LNH · Oct 4, 2004 · Radiology

Device Facts

Record ID	K042236
Device Name	G-SCAN
Applicant	Esaote, S.p.A.
Product Code	LNH · Radiology
Decision Date	Oct 4, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Indications for Use

G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections. G-scan 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), spinspin 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

G-scan is an open MRI system for imaging limbs, joints, and spinal column. System features hydraulic mechanism rotating magnet and patient table from horizontal to vertical, enabling weight-bearing scans of ankle, knee, hip, shoulder, and spine. Components include magnetic unit, electronics box, operating console (PC, monitor, keyboard/mouse), receiving coils, and modular shielding box. Operated by trained medical experts in clinical settings. Device inputs are proton spatial distribution signals; system transforms these via MR parameters (T1, T2, nuclei density, flow velocity, chemical shift) into cross-sectional images. Output images are interpreted by clinicians to provide diagnostic information, aiding clinical decision-making for musculoskeletal and spinal conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Open MRI system; 0.24 T static field intensity; 33 cm gantry opening. Gradient system: ± 20 mT/m intensity, 0.8 ms rise time. RF system: up to 1800 W peak pulse, dual 900 W amplifiers. Receiving chain: < 1 dB noise figure. Patient table: automatic longitudinal movement (140 cm) and 0-90 degree rotation. Connectivity: PC-based console. Shielding: modular box with RF/AC field attenuation. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for MR imaging of upper limbs (hand, wrist, forearm, elbow, arm, shoulder), lower limbs (foot, ankle, calf, knee, thigh, hip), and spinal column (cervical, thoracic, lumbo-sacral) in patients requiring diagnostic imaging of these anatomical regions.

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)
AIRIS II (K001334)
MAGNA SL (K940894)
Magna 5000 Phased Array CTL Spine Coil (K994345)
UROLOGIC (K011311)

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary ( i->c .Hi Esaote. S.p.A. K042236 OC1 4 - 2004 # 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specificd in 21CFR¶807.92(a). 807.92(a)(1) ## Submitter Information | Carri Graham, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 Phone: Facsimile: | (317) 849-1916 (317) 577-9070 | |----------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Contact Person: | Carri Graham | | Date: | August 13, 2004 | | 807.92(a)(2) | | | Trade Name: | G-scan | | Common Name: | Magnetic resonance diagnostic device | | Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | | Classification Number: | 90LNH | 807.92(a)(3) # Predicate Device(s) | Tradename | Common name | Class | Product code | Manufacturer | K number | |-------------------------------------------------|--------------------------------------------------|-------|--------------|----------------------------|----------| | E-scan XQ | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A. | K032121 | | AIRIS II | System, nuclear magnetic resonance imaging | II | LNH | HITACHI MEDICAL SYSTEMS | K001334 | | MAGNA SL | System, nuclear magnetic resonance imaging | II | LNH | MAGNA-LAB | K940894 | | Magna 5000 Phased Array CTL Spine Coil | Coil, Magnetic Resonance, Specialty | II | MOS | USA INSTRUMENTS | K994345 | | UROLOGIC | Table, radiographic, tilting | II | IXR | PCK ELECTRONIC INDUSTRY | K011311 | {1}------------------------------------------------ ### "01.92(a)(4) ## Device Description G-scan is an open MRI system designed specifically to image limbs, joints and the spinal column. The system is equipped with a hydraulic mechanism that will rotate both the magnet and the patient table from horizontal to vertical position, as shown in the following figures. The patient may be scanned while lying down in a horizontal position and later he can be scanned vertically, in the weight bearing state, limited to the ankle, knee, hip and shoulder joint, and the spine. The system is composed of these main parts: - 1. Magnetic unit. - 2. Electronics box. - 3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table. - 4. Receiving coils. - 5. Modular shielding box with filter panel. ### 807.92(a)(5) ### Intended Use(s) 7-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections. G-scan 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), spinspin 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. {2}------------------------------------------------ ### 307.92(a)(6) ## Technological Characteristics #### 1. Imaging System | Characteristic | G-scan | AIRIS II | Comments | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | K001334 | | | Clinical use | Portions of the upper limb, including hand, wrist, forearm, elbow, arm and shoulder. Portions of the lower limb, including foot, ankle, calf, knee, thigh and hip. Portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections. | Whole body, central nervous system and orthopaedic regions. | The spinal column has been introduced for examination. | | Pulse sequences | Turbo Spin Echo 7 | Fast Spin Echo | All the other pulse sequences are the same of E-scan XQ, K032121. The Turbo Spin Echo 7 is described in the "Device Description" section. | | Field of view | From 100 up to 350 mm, step 10 mm (250 mm are displayed). | From 50 up to 350 mm, step 1 mm | A larger FOV is available to better cover the anatomical parts to be imaged. | #### 2. Magnetic System | Characteristic | G-scan | AIRIS II K001334 | Comments | |---------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|----------| | Static field intensity | 0.24 T. | 0.3 T | | | Fringe field | 0.5 mT line at 1.8 m maximum from the centre of the magnet. | 0.5 mT line at 2.5 m maximum from the centre of the magnet. | | | Gantry opening | 33 cm high | 38 cm high | | {3}------------------------------------------------ 510(k) Summary (i-scan Esaote. S.p.A. | Characteristic | G-scan | MAGNA SL K940894 | Comments | |-----------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Field direction | Vertical or horizontal, according to system orientation, between the two "C" faces | Vertical or horizontal, according to system orientation, between the two "C" faces | The rotation of the magnet, together with the patient table, allows the weight bearing examination. The rotation system is described in the "Device Description" section. | | Characteristic | G-scan | E-scan XQ K032121 | Comments | | Homogeneity | < ± 4 ppm (FWHM) on 250 mm DSV | < ± 4 ppm (FWHM) on 140 mm DSV | A larger homogeneity region has been realized to cover the anatomical parts to be imaged. | #### 3. Gradients System | Characteristic | G-scan | E-scan XQ K032121 | Comments | |-------------------|------------------------|------------------------|-------------------------------------------------------| | Maximum Intensity | ± 20 mT/m | ± 20 mT/m | Unchanged | | Rise time | 0.8 ms (from 0 to 99%) | 0.8 ms (from 0 to 99%) | Unchanged | | Linearity | ± 5 % on 250 mm DSV | ± 5 % on 140 mm DSV | The linearity covers the homogeneity region. | #### Radiofrequency System 4. | Characteristic | G-scan | AIRIS II K001334 | Comments | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | RF power | up to 1800 W peak pulse | up to 5000 W peak pulse | | | Characteristic | G-scan | E-scan XQ K032121 | Comments | | Receiving chain | noise figure < 1 dB | noise figure < 1 dB | The receiving | | Characteristic | G-scan | E-scan XQ K032121 | Comments | | | bandwidth at 0.5 dB: 600 kHz (10.2 MHz ± 300 kHz) maximum coil/preamplifier system output -3 dBm Chain gain programmable in a 75 dB range with two gain states with 256 levels each | bandwidth at 0.5 dB: 600 kHz (7.7 MHz ± 300 kHz) maximum coil/preamplifier system output -3 dBm Chain gain programmable in a 75 dB range with two gain states with 256 levels each | chain bandwidth is centered around the center frequency of the G-scan magnet. | | Transmission Coil | 2 linear flat coils: one on the upper side and the other on the lower side of the gantry IN-impedance = 50 ohm active detuning during receiving through PIN diodes - 5 V 100 mA | linear saddle coil IN-impedance = 50 ohm active detuning during receiving through PIN diodes -5 V 100 mA | The upper and lower transmission coil of E-scan XQ are connected to obtain a single linear coil that is excited by a single 900 W RF amplifier. The upper and lower transmission coil of G-scan are not connected and each one is excited by a single 900 W RF amplifier. | | Transmission chain | 2 RF power amplifier until 900 W pep bandwidth 9.5-11.5 MHz gain stability 0.1 dB | 1 RF power amplifier until 900 W pep bandwidth 7-9 MHz gain stability 0.1 dB | The RF amplifiers of G- scan are the same of E-scan XQ, with the bandwidth centered around the center frequency of the G-scan magnet. | {4}------------------------------------------------ . {5}------------------------------------------------ | Characteristic | G-scan | Magna 5000 Phased Array | Comments | |--------------------------|---------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | CTL Spine Coil | | | | | K994345 | | | Linear receiving coil | Thoracic - Lumbar Spine coil | THORACIC CTL NB (Thoracic) and LUMBAR CTL NB (Lumbar) Coil Selections for GE OpenSpeed 0.7T Systems | The G-scan coil is a linear coil equivalent to the linear part of the Magna 5000 coil, i.e. the Magna 5000 coil without the bridges that make it a quadrature coil. The Thoracic -- Lumbar Spine coil is described in the "Device Description" section | #### 5. Patient Positioning | Characteristic | G-scan | AIRIS II | Comments | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | | | K001334 | | | Patient table | Automatic movement in longitudinal direction (referred to the patient), stroke 140 cm Manual movement in lateral direction (referred to the patient), of tabletop only, ± 25 cm Fixed height | Longitudinal automatic movement, stroke 175 cm Lateral automatic movement ± 5 cm Vertical automatic movement 45 ÷ 70 cm | The automatic movement system of G-scan is described in the "Device Description" section | | Characteristic | G-scan | UROLOGIC K011311 | Comments | |----------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Patient table | Automatic rotation, including the magnetic system, from 0 o to 90o. | Motorized tilting movement, including the x-ray tube, from - 16o to 90o. | The automatic movement system of G-scan is described in the "Device Description" section | {6}------------------------------------------------ #### Installation Area Conditions 4. | Characteristic | G-scan | AIRIS II K001334 | Comments | |----------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------| | Area necessary | 4.1 m x 3.85m (magnetic unit) 4.1m x 1.65 m (operator console and electronics box) | 4 m x 5 m (gantry and patient table) 4 m x 2.5 m (operator console, MRI unit and other components) | | | Floor load | Floor that can take a total weight of about 8500 Kg (including patient and operator). | Floor that can take a total weight of about 11300 Kg (including patient and operator). | | #### 7. Power Supply | Characteristic | G-scan | AIRIS II K001334 | Comments | |----------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|----------| | Power supply | Single phase 200/208/220/230/240 VAC, 50/60 Hz, 24 hours | Single phase 200/208/220/230/240 VAC, 8 kVA | | | Power consumption | 1200 VA during rapid heating; 3000 VA during normal operation; 450 VA with unit OFF (thermal control) | Approx. 3 kW | | | Characteristic | G-scan | E-scan XQ K032121 | Comments | |-------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Over-current release | Thermal Circuit Breaker: primary circuit: 200-240 V: 25 A secondary circuit: 20 A | Main Fuses: primary circuit: 200-240 V: 6.3 A 100-110 V: 15 A secondary circuit: 6.3 A | G-scan needs a protective device, capable of carrying and breaking greater currents | | Earthing | via power supply cable of 1.5 mm2 section | via power supply cable of 1.5 mm2 section | Unchanged | . {7}------------------------------------------------ #### Shielding box ಳ್ | Characteristic | G-scan | E-scan XQ K032121 | Comments | |----------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Attenuation | attenuation: RF 8-12 MHz E field 70 dB AC 16.6 Hz H field 1.7 AC 50/60 Hz H field 3.0 | attenuation: RF 7-9 MHz E field 70 dB AC 16.6 Hz H field 1.7 AC 50/60 Hz H field 3.0 | Unchanged | | Weight | 600 kg | 600 kg | Unchanged | | Dimensions | 3.95 x 3.65 x 2.35 (w x d x h) | 3.85 x 3.85 x 2.65 (w x d x h) | The G-scan shielding box is described in the "Device Description" section | Note: Any deviations from original E-scan XQ specifications are substantiated within Quality System documentation at Esaote S.p.A. : : {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Esaote, S.p.A. % Ms. Carrie Graham Consultant . 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K042236 OCT 4 - 2004 Trade/Device Name: G-Scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 13, 2004 Received: August 18, 2004 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. 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. {9}------------------------------------------------ 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/dsma/dsmamain.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 {10}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: G-scan Indications For Use: G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and G-scan is a Magnetic Resonance (Mrs) of the limbs, joints and spinal column. It is coronal and oblique cross-scollon images of the upper limb, including the foot, only intended for thiaging portions of the lower limb, including the foot, ankle, elbow, and shoulder, imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections. G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that G-scan images conespond to the spatial distribution connects on the MR parameters, defermine magnetic resoriation time (T1), spin-spin relaxation time (T2), nuclei density, including spiri-latilee relaxation time (11), oph specifical expert trained in the flow velocity and "chemious stillt": . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prescription Use __ × (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 A. Lyman (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number Page 1 of 1

G-SCAN

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Device Story

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Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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G-SCAN

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Special Controls

Predicate Devices

Submission Summary (Full Text)

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