C-scan is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, call and knee, but excluding the thigh.

C-scan 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 Description

The C-scan device is a magnetic resonance (MR) system. The changes performed on the C-scan device, with respect to the cleared version - Artoscan C K010057 -, are due to the improvement of the system performance. These modifications do not affect the intended use or alter the fundamental scientific technology of the device and are the following:

Upgrading of the electronics.
New pulse sequences.
A new software release.
Mobile installation.

The system is composed of three main parts:

Patient Positioning Seat
Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
Electronics and Magnetic Unit

AI/ML Overview

The provided document is a 510(k) summary for the C-scan MR system, indicating it's a submission for modifications to an already cleared device (Artoscan C K010057) rather than a de novo submission. As such, the focus is on demonstrating substantial equivalence to the predicate device, not necessarily on entirely new clinical studies to prove effectiveness or diagnostic accuracy against specific acceptance criteria for a novel device.

The "study" described here is a comparison of technical specifications and performance characteristics between the modified C-scan and the predicate Artoscan C, to show that the modifications do not alter the intended use and maintain or improve performance within the established safety and effectiveness profile of an MR diagnostic device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some fields may not be directly applicable or explicitly stated in a 510(k) summary focused on technical equivalence for an MR system upgrade:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The device under review, the C-scan MR System, is a modified version of the previously cleared Artoscan C (K010057). The acceptance criteria are implicitly based on demonstrating that the performance of the C-scan, with its upgraded electronics, new pulse sequences, new software, and mobile installation capability, is equivalent to or improved compared to the predicate device, without negatively affecting its intended use or fundamental scientific technology. The study presented is a technical comparison focusing on various system characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (Implied: Equivalence/Improvement to Predicate)	Reported Device Performance (C-scan)
Pulse Sequences	Maintained or enhanced range of pulse sequences.	New sequences added: Spin Echo T1 3D (SET1_3D), Short TI Inversion Recovery 3D (STIR_3D), Short Time Inversion Recovery Gradient Echo 3D (GE_STIR_3D), and several High Resolution sequences (se_26, se_26_hf, se_18_he, tse_80, tme, ge_16). Existing sequences retained.
Sequence Parameters	Maintained or improved parameter ranges, especially for new sequences.	SET1_3D: TR 60-5000 ms, TE 24 ms, min FOV 100 mm, FOV 3D 40-200 mm.STIR_3D: TR 150-5000 ms, TE 24 ms, TI 20-200 ms, min FOV 100 mm, FOV 3D 40-200 mm.GE_STIR_3D: TR 150-5000 ms, TE 16 ms, TI 20-200 ms, FA 90°, min FOV 100 mm, FOV 3D 40-200 mm.High Resolution Sequences: Fixed TEs (e.g., SE T1 at 26ms, GE at 16ms), increased max acquisition matrix to 512x512, ensuring best S/N for high resolution.
Spatial Resolution	Maintained or improved spatial resolution.	Improved: Up to 0.2 mm (nominal value), compared to Artoscan C's 0.4 mm. Achieved by increasing acquisition matrix (min pixel size = min FOV / max matrix size = 100x100mm / 512x512).
Acquisition Matrix	Sufficient matrices for standard & high resolution imaging.	2D FT: 192x128 to 256x256 (non-High Resolution); 192x128 to 512x512 (High Resolution).3D FT: 192x128 to 256x256, slice encoding from 24 to 128.
Control System (Gradients)	Modernized and capable control system.	Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 21062@40 MHz). Software ramp generation (from hardware).
Magnetic Compensation	Robust and technologically current compensation system.	"Open loop" control, digital elaboration of signal in separated channels (DC - 50/60 Hz - 16.6 Hz). Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (technological updating from microcontroller HC11).
A/D Conversion (RF System)	Technologically updated and efficient A/D conversion.	For each channel: 3 MHz conversion, A/D converter 14 bit 20 MHz sampling (upgrade from 2 A/D converter 16 bit 78 kHz sampling). Digital demodulation and low-pass filter with wider bandwidth.
Synthesizer (RF System)	Improved frequency, amplitude, and phase modulation capabilities and stability.	Digital, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 66 Mips). Improved resolutions (e.g., 28.4 µHz frequency, 4096 levels amplitude) and stability (< 1 ppm, < 8 x 10^-8 on 15 minutes).
Central Processing Unit	Modern and powerful CPU for image processing.	CPU Pentium IV 2.4 GHz or more, 1 GB Main memory, 512 KB Secondary cache (upgrade from Pentium III 700 MHz, 256 MB main memory, 256 MB secondary cache).
Control Processor	Upgraded control processor.	DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + 384 KB SSRAM (upgrade from DSP SHARC 21062 @ 40 MHz).
Acquisition/Reconstruction Processor	Enhanced processing power for image acquisition and reconstruction.	DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + from 256 to 512 MB SDRAM + 1.28 MB SSRAM (upgrade from DSP SHARC 21060 @ 40 MHz).
Hard Disk Unit	Increased storage capacity.	At least 40 GB, 7200 rpm (upgrade from at least 20 GB).
Image Reconstruction Matrix	Support for higher resolution images.	2D: 128x128, 256x256, 512x512 (added 512x512).3D: 256x256x24 to 256x256x128 step 8 (modified lower bound for slice encoding).
Type of Installation	Flexibility in installation.	Permanent, Mobile (added mobile installation).
Power Consumption	Characterization of power consumption.	More precise characterization with slightly reduced consumption during quick magnet heating (950 VA vs 1100 VA).

2. Sample size used for the test set and the data provenance:

This 510(k) summary primarily details technical specifications and comparisons to a predicate device. It does not describe a clinical test set in the traditional sense of patient data used for diagnostic accuracy assessment. The "study" here is a technical comparison report.
Therefore, there is no mention of a sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set. The submission focuses on inherent device performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical test set is described, there's no mention of experts establishing ground truth for such a set. The validation is based on engineering and performance metrics compared to established standards for MR systems and the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The C-scan MR System is a diagnostic imaging device, not an AI-assisted diagnostic tool. There is no mention of AI or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a hardware/software upgrade of an MR imaging system; it does not represent an "algorithm only" product for standalone performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the clinical sense. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device (Artoscan C K010057) and general regulatory requirements for MR diagnostic devices. The modifications are assessed against these technical and performance benchmarks.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI algorithm where a "training set" would be used.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned.

Summary

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MAY - 4 2004

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

510(k) Summary

Ko40877

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

807.92(a)(1)

Submitter Information

Colleen Densmore, Official Correspondent8000 Castleway Drive
Indianapolis, IN 46250
Phone:	(317) 849-1916
Facsimile:	(317) 577-9070
Contact Person:	Carri Graham
Date:	April 2, 2004
807.92(a)(2)
Trade Name:	C-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)
Esaote	Artoscan C	K010057

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801.92(a)(4)

Device Description

Summary of C-Scan modifications

The changes performed on the C-scan device, with respect to the cleared version - Artoscan C K010057 -, are due to the improvement of the system performance. These modifications do not affect the intended use or alter the fundamental scientific technology of the device and are the following:

1. Upgrading of the electronics.
1. New pulse sequences.
1. A new software release.
1. Mobile installation.

System configuration

Unmodified Artoscan C

The system is composed of three main parts:

1. Patient Positioning Scat
1. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
1. Electronics and Magnetic Unit

Modified C-scan

The system is composed of three main parts:

1. Patient Positioning Seat
1. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
1. Electronics and Magnetic Unit

807.92(a)(5)

Intended Use(s)

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Comparison to the cleared device Artoscan C K010057

Imaging system

Characteristics	Artoscan CK010057	C-scan	Comments
Pulse sequences	Orthogonal Multi-planar ScoutSpin Echo T1 (SET1)Spin Echo T2 (SET2)Multiple Spin-Echo (SE_PD_T2)Inversion Recovery (IR)Short TI Inversion Recovery (STIR)Gradient Echo (GE)Gradient Echo 3D (GE3D)Gradient Echo 3D contrastenhancement (3DCE)Half Echo T1-weighted Spin Echo(SET1HE)Half Fourier T1-weighted SpinEcho (SET1HF)Turbo SE T2 weighted and TurboME (TSE, TME)Turbo 3D T1 isotropic andanisotropic (T3D_T1)Short Time Inversion RecoveryGradient Echo (GE_STIR)Real Time	Orthogonal Multi-planar ScoutSpin Echo T1 (SET1)Spin Echo T1 3D (SET1_3D)Spin Echo T2 (SET2)Multiple Spin-Echo (SE_PD_T2)Inversion Recovery (IR)Short TI Inversion Recovery (STIR)Short TI Inversion Recovery 3D (STIR_3D)Gradient Echo (GE)Gradient Echo 3D (GE_3D)Gradient Echo 3D contrast enhancement(3DCE)Half Echo T1-weighted Spin Echo(SET1HE)Half Fourier T1-weighted Spin Echo(SET1HF)Turbo SE T2 weighted and Turbo ME (TSE,TME)Turbo 3D T1 isotropic and anisotropic(T3D_T1)Short Time Inversion Recovery GradientEcho (GE_STIR)Short Time Inversion Recovery GradientEcho (GE_STIR_3D)Real Time	The new sequences are describedin the section "Devicemodification description".
Sequenceparameters		set1 3D)TR from 60 ms to 5000 ms step 20 msTE =24 msminimum FOV 100 mm	See section "Devicemodification description".
Characteristics	Artoscan CK010057	C-scan	Comments
		FOV 3D (vol. thickness) from 40 to 200 mmstep 10 mm
		stir_3D:TR from 150 ms to 5000 ms step 10 msTE = 24 msTI from 20 ms to 200 ms, step 5 msminimum FOV 100 mm
		FOV 3D (vol. thickness) from 40 to 200 mmstep 10 mm
		ge_stir_3D:TR from 150 ms to 5000 ms step 10 msTE = 16 msTI from 20 ms to 200 ms, step 5 msFA = 90°minimum FOV 100 mm
		FOV 3D (vol. thickness) from 40 to 200 mmstep 10 mm	This is an optimized ge_stir sequence with a fixed TE, in order to maximize the Signal to Noise ratio (already present on E-scan XQ K032121).
		ge_stir_25:TR from 150 ms to 5000 ms step 10 msTE = 25 msTI from 20 ms to 200 ms, step 5 msFA = 90°minimum FOV 130 mmminimum thickness = 3 mm	The high resolution sequences are a particular version of the Artoscan C standard sequences with maximum acquisition matrix 512x512 instead of 256x256. All these sequences have a fixed TE for obtaining the best compromise between the S/N and the high resolution. High Resolution se_26: it is a Spin Echo T1 sequence
		High Resolution se_26:TR from 60 ms to 5000 ms, step 1 msTE fixed at 26 msminimum FOV 100 mmminimum slice thickness 2.0 mm
		High Resolution se_26_hf:TR from 60 ms to 5000 ms, step 10 msTE fixed at 26 ms
Characteristics	Artoscan CK010057	C-scan	Comments
		minimum FOV 100 mmminimum slice thickness 2.0 mm	with TE=26 msec.High Resolution se_26_hf:it is a Spin Echo T1 HalfFourier sequence withTE=26 msec.
		High Resolution se_18_heTR from 60 ms to 5000 ms, step 10 msTE fixed at 18 msminimum FOV 120 mmminimum slice thickness 2.0 mm	High Resolution se_18_he:it is a Spin Echo T1 HalfEcho sequence with TE=18msec.
		High Resolution tse_80:TR from 200 ms to 5000 ms, step 10 msTE fixed at 80 msminimum FOV 120 mmminimum slice thickness 3.0 mm	High Resolution tse_80: itis a Turbo Spin Echo T2sequence with TE=80 msec.High Resolution tme: it isthe high resolution versionof the standard sequence
		High Resolution tme:TR from 200 ms to 5000 ms, step 10 msTE: first echo 28 ms, second echo 90 msminimum FOV 120 mmminimum slice thickness 3.0 mm	Turbo Multi-echo.High Resolution ge_16: it isa Gradient Echo sequencewith TE=16 msec.All the high resolutionsequences are alreadypresent on E-scan XQ
		High Resolution ge_16:TR from 35 ms to 5000 ms, step 5 msTE fixed at 16 msFA from 10° to 90°, step 5°minimum FOV 130 mmminimum slice thickness 2 mm	K032121.
Acquisition Matrix:	2D FT: from 192x 128 to256x256; phase encoding step 8	2D FT for non High Resolution: from 192x128 to 256x256; phase encoding step 82D FT for High Resolution: from 192x 128to 512x512; frequency encoding step 32,phase encoding step 83D FT: from 192x128 to 256x256; slice	To perform High resolutionsequences is necessary thatthe raw data matrixdimensions are increasedi.e. it's necessary toincrease the number ofreadout (frequency)
Characteristics	Artoscan CK010057	C-scan	Comments
	slice encoding from 24 to 128, step 8; phase encoding step 8	encoding step 8	sampling points and the number of phase encoding steps.
SpatialResolution:	Up to 0.4 mm (nominal value)	Up to 0.2 mm (nominal value)	Spatial resolution is the ability to distinguish two points as separate and distinct.The nominal spatial resolution coincides with the minimum pixel size:min pixel size = min FOV / max matrix size = 100 x 100 mm / 512 x 512

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Gradients System

Characteristics	Artoscan CK010057	C-scan	Comments
Control System:	Digital, based on DSP SHARC21062 @ 40 MHz, 80 MFLOPs,with 256 KB On-Chip SRAM 3independent channels (X-Y-Z)DAC 18 bit - updating every 7.2μsHardware ramp generation –hardware pre-emphasis of eddycurrent compensation	Digital electronic, based on DSP SHARC21161@100 MHz, 400 MFLOPs, 128 KBOn-Chip SRAM3 independent channels (X-Y-Z)DAC 18 bit – update every 7.2 μsSoftware ramp generation - software pre-emphasis of eddy current suppression	The new control system isdescribed in the section"Device ModificationDescription"
Magneticcompensationsystem:	"open loop" control of themagnetic field variation withexternal measurement (AC andDC probes); digital elaborationof the signal in separatedchannels (50/60 Hz - 16.6. Hz)Digital electronic based onmicrocontroller HC11	"open loop" control of the magnetic fieldvariation with external measurement (ACand DC probes); digital elaboration of thesignal in separated channels (DC - 50/60 Hz- 16.6. Hz.Digital electronic, based on DSP SHARC21161@100 MHz, 400 MFLOPs, 128 KBOn-Chip SRAM	Technological updating.A more detailed descriptionis in the the section "Devicemodification description".

・

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Radiofrequency System

Characteristics	Artoscan CK010057	C-scan	Comments
A/D Conversion:	baseband conversion anddemodulation of the RF receivedsignal in phase and quadraturecomponents2 A/D converter 16 bit 78 kHzsampling2 digital low-pass filter foranalogical phase and quadraturecomponents; bandwidth: gain 1up to 0.464xfc, con fc = 78.125KHz/n, n=1+10; stop-band: from0.5xfc; attenuation 90 dB.	For each channel:3 MHz conversion of the RF received signalA/D converter 14 bit 20 MHz samplingdigital demodulation in phase and quadraturecomponentsdigital low-pass filter; bandwidth: gain 1 upto 0.43 x fc, with fc from 156.25 to 4.882kHz; stop-band: from 0.5 x fc; attenuation 90dB.Transferring to DSPM of raw data real andimaginary parts.	Technological updating.A more detailed decriptionis in the the section "Devicemodification description".
Synthesizer:	digital, through DSP SHARC 66Mips, 132 MFlops, 0.5 MbitMemory on the chip, withfrequency, amplitude and phasemodulationresolutions: 1,2 Hz frequency,256 levels amplitude, 1°.4 phasestability : < 1 ppm into theoperative temperature rangetransmission variable gain: 256levels	digital, through DSP SHARC 21161@100MHz, 400 MFLOPs, 128 KB On-ChipSRAM, with frequency, amplitude and phasemodulationresolutions: 28.4 µHz frequency, 4096 levelsamplitude, 1°.19 phasestability : < 1 ppm into the operativetemperature range;≤ 8 x 10-8 on 15 minutes (maximumvariation 0,75°C)transmission variable gain: 256 levels	Technological updating.A more detailed decriptionis in the the section "Devicemodification description".

Image Processing and Display System

Characteristics	Artoscan CK010057	C-scan	Comments
CentralProcessing Unit	ISA and PCI BusCPU Pentium III 700 MHz or fastermain memory: 256 MBsecondary cache memory: 256 KB orupper	PCI busCPU Pentium IV 2.4 GHz or moreMain memory: 1 GBSecondary cache memory: 512 KB or more	Technological updating

L T

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Characteristics	Artoscan CK010057	C-scan	Comments
Control processor	DSP SHARC 21062 @ 40 MHz, 80 MFLOPs, with 256 KB On-Chip SRAM	DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + 384 KB SSRAM	Technological updating
Acquisition andreconstructionprocessor:	DSP SHARC 21060 @ 40 MHz, 80 MFLOPs, with 512 KB On-Chip SRAM + 128 MB DRAM	DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + from 256 to 512 MB SDRAM + 1.28 MB SSRAM	Technological updating
Hard Disk Unit:	3"1/2 hard disk; at least 20 GB, 7200 rpm	3"1/2 hard disk; at least 40 GB, 7200 rpm	Technological updating
ImageReconstructionMatrix:	2D: 256x2563D: 256x256x8 to 256x256x128 step 8	2D: 128x128, 256x256, 512x5123D: 256x256x24 to 256x256x128 step 8	The visualization matrix of the images obtained by the high resolution sequences can be 128x128, 256x256 or 512x512 pixels.

Installation Area Conditions

Characteristics	Artoscan CK010057	C-scan	Comments
Type ofinstallation:	Permanent	Permanent, Mobile	The mobile installation isdescribed in the section"Device modificationdescription".

Power supply

Characteristics	Artoscan CK010057	C-scan	Comments
Powerconsumption:	1100 VA during quick magnetheating600 VA during normal working150 VA when unit is powered off(thermal control on)	950 VA during quick magnet heating600 VA during normal working150 VA when unit is powered off (thermalcontrol on)	More precisecharacterization of the data.

Note: Any deviations from original Artoscan C specifications are substantiated within Quality System documentation at Essote S.p.A..

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2004

Esaote, S.p.A. % Ms. Carrie Graham Official Correspondent The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K040877 Trade/Device Name: C-scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 LNH Dated: April 2, 2004 Received: April 5, 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 (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.

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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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): 《o 4 0 8 7 7

Device Name: C-scan MR System

Indications for Use:

C-scan is a magnetic resonance (MR) system that produces transversal, sagittal and C-scan is a magnetic resoliance (inter byoten and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding imaging portions of the ann, meluding the halls, misq costing the foot, ankle, calf and knee, but excluding the thigh.

C-scan 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), nucled density. including spin=atticc relaxation time (11), species now velocity and "chemical start " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

X : 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 CDRII, Office of Device Evaluation (ODE)

David A. Syverson

(Division Sign-Off) Division of Reproductive, Abdomin 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.