S-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 hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-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

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 operating table.
Electronics box with filter panel.

AI/ML Overview

The provided text is a 510(k) summary for the S-scan MRI system. It describes the device, its intended use, and technological characteristics compared to predicate devices. However, it does not contain information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).

The document focuses on demonstrating substantial equivalence to existing MRI systems based on similar technology and intended use, rather than presenting a detailed performance evaluation with specific acceptance criteria as one might expect for a new diagnostic algorithm or AI-powered device.

Therefore, I cannot populate the requested tables and information based on the provided text. The document primarily highlights modifications to an existing G-scan MRI system (K042236) and its similarity to other predicate devices like the E-scan Opera (K060956) and Siemens Magnetom C! (K043030).

The "Comments" column in the "Technological Characteristics" table mentions that some S-scan features (like oversampling and gradient moment nulling) are already in place on other commercial scanners (e.g., MAGNETOM C! K043030). This suggests that the substantial equivalence argument relies on the established performance of similar technologies in predicate devices, rather than a new, independent performance study with defined acceptance criteria for the S-scan.

Summary

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K063207

510(k) Summary

NOV - 9 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 (317) 569-9500 X 103 Phone: (317) 569-9520 Facsimile:

Contact Person: Carri Graham

October 19, 2006 Date:

807.92(a)(2)

Trade Name:	S-scan
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	G-scan	K042236
Esaote	E-scan Opera	K060956-
Siemens	Magnetom C!	K043030
USA Instruments	Magna 5000Phased ArrayCTL Spine Coil	K994345

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807.92(a)(4)

Device Description

Summary of G-scan modifications

The changes performed on the modified G-scan device (S-scan), with respect to the cleared version - G-scan K042236 -, 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 new patient table that can be moved only manually. Neither the patient table nor the magnet can rotate from horizontal to vertical position.
1. A modified support to hold up the magnet and the gantry.
1. A new display panel on the front of the magnet.
1. Some different external covers due to the new patient table and support.
1. Upgrading of the electronics.
1. Two new receiving coils: DPA Lumbar spine coil N.10 and Cervical spine coil N.9
1. Modified pulse sequences
1. A modified version of the magnet poles and of the gradient coils.
1. A new software release.

S-scan

The system is composed of these main parts:

1. Patient positioning table.
1. Magnetic unit with the display panel.
1. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
1. Electronics box with filter panel.

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807.92(a)(5)

Intended Use(s)

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR paranteters, including spin-lattice relaxation time (TI), 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.

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807.92(a)(6)

Technological Characteristics

Characteristic	S-scan	G-scan K042236	Comments
Pulse Sequences	Orthogonal Multi-planar Scout	Orthogonal Multi-planar Scout	The S-scan pulsesequences are amodified versionof the G-scanpulse sequencesas described inthe DeviceModificationDescription andSoftwareDescriptionsections.
	Spin Echo T1	Spin Echo T1
	Spin Echo T2	Spin Echo T2
	Spin Echo Proton Density T2	Spin Echo Proton Density T2
	Inversion Recovery	Inversion Recovery
	Short TI Inversion Recovery	Short TI Inversion Recovery
	Spin Echo T1 Half Echo	Spin Echo T1 Half Echo
	Spin Echo T1 Half Fourier	Spin Echo T1 Half Fourier
	Turbo Spin Echo T2 weighted(TSE, TSE S, TSE SA, TSE SP)	Turbo Spin Echo T2 weighted(TSE)
	Turbo Multi Echo	Turbo Multi Echo
	Gradient Echo	Gradient Echo
	Short Time Inversion Recovery	Short Time Inversion Recovery
	Gradient Echo (Gradient EchoSTIR)	Gradient Echo (Gradient EchoSTIR)
	Gradient Echo 3D (Turbo 3D T1)	Gradient Echo 3D (Turbo 3D T1)
	Speed — Spin Echo T2 (SSE-SET2,SSE-SET2 S, SSE-SET2 SA, SSE-SET2 SP)
	Speed — Spin Echo T2 (SSE-SET2# 1-2-3)
	Real Time	Real Time
Receiving coils	1 Shoulder coil	1 Shoulder coil	The linear coilof the DPALumbar Spinecoil n.10 is equalto the Thoracic—Lumbar Spinecoil n.8. Thewhole coil isequivalent to theMagna 5000Phased ArrayCTL Spine CoilK994345,available onothercommercialscanners.See DeviceModificationDescriptionsection
	2 Knee coil	2 Knee coil
	3 Hand coil	3 Hand coil
	4 Foot/Ankle coil	4 Foot/Ankle coil
	6 Flexible coil	6 Flexible coil
	7 Shoulder coil	7 Shoulder coil
	9 Cervical Spine coil	8 Thoracic — Lumbar Spine coil
	10 Lumbar Spine coil	9 Cervical Spine coil
Characteristic	S-scan	G-scan K042236	Comments
Multi-channelreconstruction	SoS technique		This technique isalready in placeon many multi-channel MRIsystems as, forinstance,MAGNETOMC! (K043030).See DeviceModificationDescriptionsection.
Indications forUse	S-scan is a Magnetic Resonance(MR) system that producestransversal, sagittal and coronaland oblique cross-section imagesof the limbs, joints and spinalcolumn. It is intended for imagingportions of the upper limb,including the hand, wrist, forearm,elbow, arm and shoulder, imagingportions of the lower limb,including the foot, ankle, calf,knee, thigh and hip and imagingportions of the spinal column,including the cervical and lumbo-sacral sections.S-scan images correspond to thespatial distribution of protons(hydrogen nuclei) that determinemagnetic resonance properties andare dependent on the MRparameters, including spin-latticerelaxation time (T1), spin-spinrelaxation time (T2), nucleidensity, flow velocity and"chemical shift". When interpretedby a medical expert trained in theuse of MR equipment, the imagescan provide diagnostically usefulinformation.	G-scan is a Magnetic Resonance(MR) system that producestransversal, sagittal and coronaland oblique cross-section imagesof the limbs, joints and spinalcolumn. It is intended for imagingportions of the upper limb,including the hand, wrist, forearm,elbow, arm and shoulder, imagingportions of the lower limb,including the foot, ankle, calf,knee, thigh and hip and imagingportions of the spinal column,including the cervical, thoracic andlumbo-sacral sections.G-scan images correspond to thespatial distribution of protons(hydrogen nuclei) that determinemagnetic resonance properties andare dependent on the MRparameters, including spin-latticerelaxation time (T1), spin-spinrelaxation time (T2), nucleidensity, flow velocity and"chemical shift". Wheninterpreted by a medical experttrained in the use of MR equipment,the images can providediagnostically useful information.
Characteristic	S-scan	E-scan Opera K060956	Comments
Patient table	Maximum load-bearing capacity =200 kg (approx. 440 lb)fixed height (740 cm)it can be rotated and removed frommagnet cavity to facilitate patientpositioning andto enable various positions inrelation to the region examinedwashable covering materialmanual positioningintegrated in overall design ofequipment.	Maximum load-bearing capacity =200 kg (approx. 440 Ib)fixed height (710 cm)removable from magnet cavity tofacilitate patient positioningone section of the bed can berotated to enable various positionsin relation to the region examinedwashable covering materialmanual positioningintegrated in overall design ofequipment.	See DeviceModificationDescriptionsection
Magnetic unitdisplay panel	The function of the Display Panelis displaying real time sequencesfor patient positioning.Present commands:Preview: begins the real timesequence and displays the acquiredimage on the LCD panel in theselected orientation (sagittal, axial,coronal).Abort: stops the running sequence.integrated in overall design ofequipment.	The function of the Display Panelis displaying real time sequencesfor patient positioning.Present commands:Preview: begins the real timesequence and displays the acquiredimage on the LCD panel in theselected orientation (sagittal, axial,coronal).Abort: stops the running sequence.integrated in overall design ofequipment.	See DeviceModificationDescriptionsection
Electronics box	ALDIM unit: supplies the DisplayPanel.	ALDIM unit: supplies the DisplayPanel.	See DeviceModificationDescriptionsection.
Imagevisualization	RF saturation pulses to suppressflow and motion artifacts.The Repetition Time (TR) of eachsequence can be set using fixedstep so that 50 or 60 Hz artifactscan be avoided.Algorithm to avoid wrap aroundartifacts through oversampling.Flow compensation through theGradient moment nullingtechnique.	RF saturation pulses to suppressflow and motion artifacts.The Repetition Time (TR) of eachsequence can be set using fixedstep so that 50 or 60 Hz artifactscan be avoided.	Theoversamplingand the gradientmoment nulling(GMR -Gradient MotionRephasing) areavailable onothercommercialscanners as, forinstance,MAGNETOMC! (K043030).See SoftwareDescriptionsection

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Image /page/6/Picture/1 description: The image shows a logo with a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. To the left of the bird symbol, there is text arranged in a circular fashion, which appears to be the name of an organization or department. The text is oriented to follow the curve of the circle, and the overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032

NOV - 9 2006

Re: K063207

Trade/Device Name: S-scan MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 19, 2006 Received: October 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/6/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a cursive font. There are three small dots arranged horizontally at the bottom of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean

Page 2 -

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.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

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Indications for Use

510(k) Number (if known): _ KOGS20 |

K063207

Device Name: S-scan MRI System

Indications for Use:

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)

Page 1 of 1

Nancy C Broadon

(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

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.