G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section 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), 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.

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.
1. Electronics box.
1. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
1. Receiving coils.
1. Modular shielding box with filter panel.

AI/ML Overview

The provided text is a 510(k) summary for the Esaote G-scan MRI system. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for performance claims of a new medical device.

The 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices, primarily by comparing technical specifications. It highlights similarities and differences between the G-scan and predicate devices (E-scan XQ, AIRIS II, MAGNA SL, Magna 5000 Phased Array CTL Spine Coil, UROLOGIC table). The "Comments" sections in the tables explicitly state "Unchanged," "similar," or describe differences in technical parameters, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information based on the provided document. The document presents a technical comparison for substantial equivalence, not a performance study with defined acceptance criteria and results.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This document provides technical specifications and comparisons to predicate devices, but no explicit acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity) and no corresponding reported performance from a clinical study.
Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
Adjudication method for the test set: Not applicable as no performance study is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device described is an MRI system, not an AI-powered diagnostic tool, and no human-in-the-loop study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a traditional MRI system, not an algorithm.
The type of ground truth used: Not applicable as no performance study is described.
The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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 Correspondent8000 Castleway DriveIndianapolis, IN 46250Phone: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, nuclearmagnetic resonanceimaging	II	LNH	ESAOTE S.P.A.	K032121
AIRIS II	System, nuclearmagnetic resonanceimaging	II	LNH	HITACHI MEDICALSYSTEMS	K001334
MAGNA SL	System, nuclearmagnetic resonanceimaging	II	LNH	MAGNA-LAB	K940894
Magna 5000Phased ArrayCTL SpineCoil	Coil, MagneticResonance, Specialty	II	MOS	USA INSTRUMENTS	K994345
UROLOGIC	Table, radiographic,tilting	II	IXR	PCK ELECTRONICINDUSTRY	K011311

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"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 system is composed of these main parts:

1. Magnetic unit.
1. Electronics box.
1. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
1. Receiving coils.
1. 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.

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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 andshoulder.Portions of the lower limb,including foot, ankle, calf,knee, thigh and hip.Portions of the spinalcolumn, including thecervical, thoracic andlumbo-sacral sections.	Whole body, centralnervous system andorthopaedic regions.	The spinalcolumn has beenintroduced forexamination.
Pulse sequences	Turbo Spin Echo 7	Fast Spin Echo	All the otherpulse sequencesare the same ofE-scan XQ,K032121.The Turbo SpinEcho 7 isdescribed in the"DeviceDescription"section.
Field of view	From 100 up to 350 mm,step 10 mm (250 mm aredisplayed).	From 50 up to 350 mm,step 1 mm	A larger FOV isavailable tobetter cover theanatomical partsto be imaged.

2. Magnetic System

Characteristic	G-scan	AIRIS IIK001334
Static fieldintensity	0.24 T.	0.3 T
Fringe field	0.5 mT line at 1.8 mmaximum from the centreof the magnet.	0.5 mT line at 2.5 mmaximum from the centreof the magnet.
Gantry opening	33 cm high	38 cm high

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510(k) Summary (i-scan Esaote. S.p.A.

Characteristic	G-scan	MAGNA SLK940894	Comments
Field direction	Vertical or horizontal,according to systemorientation, between thetwo "C" faces	Vertical or horizontal, accordingto system orientation, betweenthe two "C" faces	The rotation ofthe magnet,together with thepatient table,allows theweight bearingexamination.The rotationsystem isdescribed in the"DeviceDescription"section.
Characteristic	G-scan	E-scan XQK032121	Comments
Homogeneity	< ± 4 ppm (FWHM) on250 mm DSV	< ± 4 ppm (FWHM) on140 mm DSV	A largerhomogeneityregion has beenrealized to coverthe anatomicalparts to beimaged.

3. Gradients System

Characteristic	G-scan	E-scan XQK032121	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 linearitycovers thehomogeneityregion.

Radiofrequency System 4.

Characteristic	G-scan	AIRIS IIK001334	Comments
RF power	up to 1800 W peakpulse	up to 5000 W peak pulse
Characteristic	G-scan	E-scan XQK032121	Comments
Receiving chain	noise figure < 1 dB	noise figure < 1 dB	The receiving
Characteristic	G-scan	E-scan XQK032121	Comments
	bandwidth at 0.5 dB:600 kHz (10.2 MHz ±300 kHz)maximumcoil/preamplifiersystem output -3dBmChain gainprogrammable in a 75dB range with twogain states with 256levels each	bandwidth at 0.5 dB: 600 kHz(7.7 MHz ± 300 kHz)maximum coil/preamplifiersystem output -3 dBmChain gain programmable in a75 dB range with two gainstates with 256 levels each	chain bandwidthis centeredaround the centerfrequency of theG-scan magnet.
Transmission Coil	2 linear flat coils: oneon the upper side andthe other on the lowerside of the gantryIN-impedance = 50ohmactive detuningduring receivingthrough PIN diodes -5 V 100 mA	linear saddle coilIN-impedance = 50 ohmactive detuning duringreceiving through PIN diodes-5 V 100 mA	The upper andlowertransmission coilof E-scan XQ areconnected toobtain a singlelinear coil that isexcited by asingle 900 W RFamplifier. Theupper and lowertransmission coilof G-scan are notconnected andeach one isexcited by asingle 900 W RFamplifier.
Transmissionchain	2 RF power amplifieruntil 900 W pepbandwidth 9.5-11.5MHzgain stability 0.1 dB	1 RF power amplifier until900 W pepbandwidth 7-9 MHzgain stability 0.1 dB	The RFamplifiers of G-scan are thesame of E-scanXQ, with thebandwidthcentered aroundthe centerfrequency of theG-scan magnet.

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Characteristic	G-scan	Magna 5000 Phased Array	Comments
		CTL Spine Coil
		K994345
Linear receivingcoil	Thoracic - LumbarSpine coil	THORACIC CTL NB(Thoracic) and LUMBARCTL NB (Lumbar)Coil Selections for GEOpenSpeed 0.7T Systems	The G-scan coilis a linear coilequivalent to thelinear part of theMagna 5000coil, i.e. theMagna 5000 coilwithout thebridges thatmake it aquadrature coil.The Thoracic --Lumbar Spinecoil is describedin the "DeviceDescription"section

5. Patient Positioning

Characteristic	G-scan	AIRIS II	Comments
		K001334
Patient table	Automatic movement inlongitudinal direction(referred to the patient),stroke 140 cmManual movement inlateral direction (referredto the patient), of tabletoponly, ± 25 cmFixed height	Longitudinal automaticmovement, stroke 175 cmLateral automaticmovement ± 5 cmVertical automaticmovement 45 ÷ 70 cm	The automaticmovement system ofG-scan is describedin the "DeviceDescription" section

Characteristic	G-scan	UROLOGICK011311	Comments
Patient table	Automatic rotation, includingthe magnetic system, from 0 o to90o.	Motorized tilting movement,including the x-ray tube, from -16o to 90o.	The automaticmovement system ofG-scan is describedin the "DeviceDescription" section

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Installation Area Conditions 4.

Characteristic	G-scan	AIRIS IIK001334	Comments
Area necessary	4.1 m x 3.85m (magnetic unit)4.1m x 1.65 m (operator console andelectronics box)	4 m x 5 m (gantry andpatient table)4 m x 2.5 m (operatorconsole, MRI unit andother components)
Floor load	Floor that can take a totalweight of about 8500 Kg(including patient andoperator).	Floor that can take a totalweight of about 11300 Kg(including patient andoperator).

7. Power Supply

Characteristic	G-scan	AIRIS IIK001334	Comments
Power supply	Single phase200/208/220/230/240 VAC,50/60 Hz, 24 hours	Single phase200/208/220/230/240VAC, 8 kVA
Powerconsumption	1200 VA during rapid heating;3000 VA during normaloperation;450 VA with unit OFF(thermal control)	Approx. 3 kW

Characteristic	G-scan	E-scan XQK032121	Comments
Over-currentrelease	Thermal Circuit Breaker:primary circuit:200-240 V: 25 Asecondary circuit: 20 A	Main Fuses:primary circuit:200-240 V: 6.3 A100-110 V: 15 Asecondary circuit: 6.3 A	G-scan needsa protectivedevice,capable ofcarrying andbreakinggreatercurrents
Earthing	via power supply cable of 1.5mm2 section	via power supply cable of1.5 mm2 section	Unchanged

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Shielding box ಳ್

Characteristic	G-scan	E-scan XQK032121	Comments
Attenuation	attenuation:RF 8-12 MHz E field 70 dBAC 16.6 Hz H field 1.7AC 50/60 Hz H field 3.0	attenuation:RF 7-9 MHz E field 70 dBAC 16.6 Hz H field 1.7AC 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-scanshielding boxis describedin the"DeviceDescription"section

Note: Any deviations from original E-scan XQ specifications are substantiated within Quality System documentation at Esaote S.p.A.

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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.

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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

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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

Regulation Number and Section

§ 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.