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.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

Device Description

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, 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 device that locks the patient table in the current position, unless the user disconnects the coil cable.
1. A limb protection for patient table.
1. Modified pulse sequences.
1. A new software release.

AI/ML Overview

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
Modifications to the S-scan (K063207):
- Device that locks the patient table.
- Limb protection for the patient table.
- Modified pulse sequences.
- A new software release.
Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

Summary

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K080968

APR 2 9 2008

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

Submitter Information 807.92(a)(1)

Carri Graham, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 Phone: (317) 569-9500 X 103 Facsimile: (317) 569-9520

Contact Person: Carri Graham

Date: April 3, 2008

807.92(a)(2)

Trade Name: S-scan System, Nuclear Magnetic Resonance Imaging Common Name: Classification Name(s): Magnetic resonance diagnostic device Classification Number: 90LNH

807.92(a)(3)	Predicate Device(s)
Esaote	S-scan	K063207
Esaote	G-scan	K042236
Siemens	Magnetom C!	K043030
Esaote	Dynamic MRISoftware forC-scan, E-scan XQ,& E-scan Opera	K061429
Siemens	Syngo MultimodalityWorkstation	K010938

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807.92(a)(4)

Device Description

Summary of S-scan modifications

1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
1. A limb protection for patient table.
1. Modified pulse sequences.
1. A new software release.

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807.92(a)(5)

Intended Use(s)

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807.92(a)(6)

Technological Characteristics

Characteristic	S-scanmodified	S-scanK063207	Comments
Pulse Sequences	Orthogonal Multi-planar ScoutSpin Echo T1Spin Echo T2Spin Echo Proton Density T2Inversion RecoveryShort TI Inversion RecoverySpin Echo TI Half EchoSpin Echo TI Half FourierTurbo Spin Echo T2 weighted(TSE, TSE S, TSE SA, TSE SP)Turbo Multi EchoGradient EchoShort Time Inversion RecoveryGradient Echo (Gradient EchoSTIR)Gradient Echo 3D (Turbo 3DT1)Speed - Spin Echo T2 (SSE-SET2, SSE-SET2 S, SSE-SET2SA, SSE-SET2 SP)Speed - Spin Echo T2 (SSE-SET2 # 1-2-3)FSE (FSE T1, FSE STIR, FSET2)3D HYCEXBONEReal Time	Orthogonal Multi-planar ScoutSpin Echo T1Spin Echo T2Spin Echo Proton Density T2Inversion RecoveryShort TI Inversion RecoverySpin Echo TI Half EchoSpin Echo T1 Half FourierTurbo Spin Echo T2 weighted(TSE, TSE S, TSE SA, TSE SP)Turbo Multi EchoGradient EchoShort Time Inversion RecoveryGradient Echo (Gradient EchoSTIR)Gradient Echo 3D (Turbo 3DT1)Speed - Spin Echo T2 (SSE-SET2, SSE-SET2 S, SSE-SET2SA, SSE-SET2 SP)Speed - Spin Echo T2 (SSE-SET2 # 1-2-3)Real Time	The modified S-scanpulse sequences aredescribed in theDevice ModificationDescription.
Sequenceparameters	Spin Echo T1, TE=16 ms:TR: from 50 to 5000 ms, step 10msTE: 16 msFA: 90°FOV: from 100 to 300 mm, step10 mmSlice thickness: from 2 to 10mm, step 0.5 mm	See comments	This is a particularversion of standardSpin echo T1 with TEfixed at 16 ms, insteadof 18 ms.
Sequenceparameters	Speed - Spin Echo T2 #1:TR: from 200 to 5000 ms, step10 msTE: 130 msFA: 90°FOV: from 250 to 400 mm, step10 mmSlice thickness: from 4 to 10mm, step 0.5 mmSpeed - Spin Echo T2 #2:	See comments	The Speed Spin EchoT2 #1, 2, 3 are theSpin Echo T2 #1, 2, 3sequence with Speedtechnique forreduction of scantime.
Characteristic	S-scanmodified	S-scanK063207	Comments
	10 msTE: 130 msFA: 90°FOV: from 250 to 400 mm, step10 mmSlice thickness: from 4 to 10mm, step 0.5 mm
	Speed - Spin Echo T2 #3:TR: from 200 to 5000 ms, step10 msTE: 130 msFA: 90°FOV from 250 to 400 mm, step10 mmSlice thickness: from 4 to 10mm, step 0.5 mm
Sequenceparameters	FSE T2ESP: 20 ms, 30 msETL: from 8 to 12 (depending ofESP selected), step 2TR: from 100 to 10000 ms, step10 msTE: from 20 to 300 ms, step 20ms or 30 ms (depending of ESPand ETL selected)FA: 90°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 3 to 7 mm,step 0.5 mmFlow compensation: None/Read/SelRelaxation: Yes/NoFSE STIR:ESP: 20 ms, 30 msETL: from 2 to 6 (depending ofESP selected), step 2TR: from 100 to 10000 ms, step10 msTE: from 20 to 120 ms, step 20ms or 30 ms (depending of ESPand ETL selected)TI: from 60 to 300 ms, step 5 msFA: 90°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 3 to 7 mm,step 0.5 mmFlow compensation: None/Read/Sel	See comments	See DeviceModificationDescription -Modified pulsesequences section.
Characteristic	S-scanmodified	S-scanK063207	Comments
	FSE T1ESP: 20 msETL: 2, 3TR: from 100 to 10000 ms, step10 msTE: from 20 to 60 ms, step 20ms (depending of ETL selected)FA: 90°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 3 to 7 mm,step 0.5 mm
Sequenceparameters	GE T2 FC:TR: from 30 to 5000 ms, step 5msTE: from 22 to 34 ms, step 4 msFA: from 10° to 90°, step 5°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 2 to 10mm, step 0.5 mm	See comments	This is a particularversion of theGradient echo T2standard sequencewith application ofgradient momentnulling technique forflow compensation.See SoftwareDescription -SoftwareRequirementsSpecifications section.
Sequenceparameters	Gradient Echo, TE=6 ms:TR: from 30 to 5000 ms, step 5msTE: 6 msFA: from 10° to 90°, step 5°.FOV: from 130 to 300 mm, step10 mmSlice thickness: from 4 to 10mm, step 0.5 mm	See comments	This is a Gradientecho sequence withfixed TE at 6 ms thatprovides "pseudoTl"contrast images.
Sequenceparameters	STIR T2 S:TR: from 200 to 10000 ms, step10 msTE: from 120 to 130 ms, step10 msTI: from 50 to 2000 ms, step 5msFA: 90°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 3 to 10mm, step 0.5 mm	See comments	This is a STIRstandard sequencewith 4 echoes insteadof 3 that are combinedto obtain T2-weightedcontrast images withbetter S/N.
Sequenceparameters	STIR T2 A:TR: from 200 to 10000 ms, step10 msTE: from 80 to 120 ms, step 10 ms	See comments	This is a particularversion STIR standarsequence where thesequence parameters
Characteristic	S-scanmodified	S-scanK063207	Comments
	msTI: from 50 to 2000 ms, step 5msFA: 90°FOV: from 120 to 400 mm, step10 mmSlice thickness: from 3 to 10mm, step 0.5 mm		are optimized for jointvisualization.
Sequenceparameters	XBONETR: from 50 to 5000 ms, step 10msFA: from 10° to 90°, step of 5°FOV: from 100 to 400 mm, step10 mmSlice thickness: from 2 to 10mm, step 0.5 mm	See comments	See DeviceModificationDescription - sectionModified pulsesequences.
Sequenceparameters	3D HYCETR: from 10 to 13 msTE: TR/2FA: from 60° to 90°FOV: from 200 to 300 mm, step10 mmFOV 3D: from 80 to 160 mm,step 10 mmSlice thickness: from 0.8 to 20mm, step 0.1 mm	See comments	See DeviceModificationDescription -Modified pulsesequences section.
Characteristic	S-scanmodified	G-scanK042236	Comments
Pulse sequences	FSE (FSE T1, FSE STIR, FSET2)	Turbo Spin Echo - 7	See DeviceModificationDescription –Modified pulsesequences section.
Characteristic	S-scanmodified	MAGNETOM C!K043030	Comments
Pulse sequences	FSE T2 with relaxationtechnique	RESTORE sequence	See DeviceModificationDescription –Modified pulsesequences section.
Characteristic	S-scanmodified	MAGNETOM C!K043030	Comments
Pulse sequences	3D HYCE	trueFISP	See DeviceModificationDescription -Modified pulsesequences section.

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Characteristic	S-scanmodified	MAGNETOM C!K043030	Comments
Pulse sequences	XBONE	Dixon Fat Suppression	See DeviceModificationDescription –Modified pulsesequences section.

Characteristic	S-scanmodified	Dynamic MRI SoftwareK061429	Comments
ImageProcessingFunctions	Dynamic MRI studyenvironment:- Display by group- Automatic registration ofthe group's images- Generate, save and exportof uptake curves and ofcomparison between twodifferent uptake curves- Management of dynamicacquisition by pedal switch(identification of thedynamic acquisition startingtime)	Dynamic MRI studyenvironment:- Display by group- Generate, save and export ofuptake curves.	The registrationtechnique is alreadyin place on manydiagnostic imagingdevices or post-processingworkstations as, forinstance, syngoMultimodalityWorkstation - featureImageFusion(K010938).See SoftwareDescription -SoftwareRequirementsSpecificationssection.
Characteristic	S-scan modified	S-scanK063207	Comments
Networkingfunctions	Possibility of reading,writing and update of CD-Rand DVD in DICOMformat, (FSC, FSR, FSUGeneral Purpose CD-RImage Interchange Profile,MR images only).Possibility of exportingimages both in DICOM andin jpeg format on the sameremovable media (at leastthe DICOM format isalways present).	Possibility of reading, writingand update of CD-R in DICOMformat, (FSC, FSR, FSUGeneral Purpose CD-R ImageInterchange Profile, MR imagesonly).	See SoftwareDescription -SoftwareRequirementsSpecifications section.
Access to thesystem	Management, only bysystem administrator, oftwo levels of security.Possibility, only by systemadministrator, to reset thepassword of the users.	Management of multiple userswith automatic expiry ofpassword and account (if notused).	See SoftwareDescription -SoftwareRequirementsSpecifications section.
Accessories	Viewer Lite:	Viewer Lite:	See SoftwareDescription -

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Characteristic	S-scanmodified	S-scanK063207	Comments
	- export on a CD/DVD anddisplay on a commercial PCof the Esaote's MRI images- copy of the Viewer Liteuser manual on theCD/DVD	- export on a CD/DVD anddisplay on a commercial PCof the Esaote's MRI images.	SoftwareRequirementsSpecifications section.

and the comments of the comments of the comments of

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Official Consultant The Anson Group, LLC 1460 N. Meridian St., Suite 150 CARMEL IN 46032

APR 2 9, 2008

Re: K080968

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: April 3, 2008 Received: April 4, 2008

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 (PMA), 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.

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Enclosure

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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: S-scan MRI System

Indications for Use:

S-scan is a Magnetic Resonance (MR) system that produces transverse, 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.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080968

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.