(29 days)
No
The summary describes a standard MR imaging system with hardware and software upgrades focused on performance improvement and new pulse sequences, with no mention of AI or ML capabilities for image analysis or interpretation.
No.
The device is described as an MR system that produces images for diagnosis, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device produces cross-section images of limbs and joints, and "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This explicitly indicates its role in providing diagnostic information.
No
The device description explicitly states that the C-scan device is a magnetic resonance (MR) system composed of a Patient Positioning Seat, Operating console (including PC, monitor, table), and Electronics and Magnetic Unit. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- C-scan's Function: The C-scan is a magnetic resonance (MR) system that produces images of the limbs and joints directly from the patient's body. It does not analyze specimens taken from the body.
- Imaging Modality: Magnetic resonance imaging is an in vivo imaging technique, meaning it is performed on a living organism.
Therefore, the C-scan device, as described, falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
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.
System configuration
Unmodified Artoscan C
The system is composed of three main parts:
-
- Patient Positioning Scat
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Electronics and Magnetic Unit
Modified C-scan
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Limbs and joints. Specifically, portions of the arm (hand, wrist, forearm, elbow, excluding upper arm) and portions of the leg (foot, ankle, calf, knee, excluding thigh).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert trained in the use of MR equipment / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Correspondent
| 8000 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 |
1
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:
-
- Upgrading of the electronics.
-
- New pulse sequences.
-
- A new software release.
-
- Mobile installation.
System configuration
Unmodified Artoscan C
The system is composed of three main parts:
-
- Patient Positioning Scat
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Electronics and Magnetic Unit
Modified C-scan
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
807.92(a)(5)
Intended Use(s)
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.
2
Comparison to the cleared device Artoscan C K010057
Imaging system
| Characteristics | Artoscan C
K010057 | C-scan | Comments |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse sequences | Orthogonal Multi-planar Scout
Spin 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 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
Gradient Echo (GE_STIR)
Real Time | Orthogonal Multi-planar Scout
Spin 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 Gradient
Echo (GE_STIR)
Short Time Inversion Recovery Gradient
Echo (GE_STIR_3D)
Real Time | The new sequences are described
in the section "Device
modification description". |
| Sequence
parameters | | set1 3D)
TR from 60 ms to 5000 ms step 20 ms
TE =24 ms
minimum FOV 100 mm | See section "Device
modification description". |
| Characteristics | Artoscan C
K010057 | C-scan | Comments |
| | | FOV 3D (vol. thickness) from 40 to 200 mm
step 10 mm | |
| | | stir_3D:
TR from 150 ms to 5000 ms step 10 ms
TE = 24 ms
TI from 20 ms to 200 ms, step 5 ms
minimum FOV 100 mm | |
| | | FOV 3D (vol. thickness) from 40 to 200 mm
step 10 mm | |
| | | ge_stir_3D:
TR from 150 ms to 5000 ms step 10 ms
TE = 16 ms
TI from 20 ms to 200 ms, step 5 ms
FA = 90°
minimum FOV 100 mm | |
| | | FOV 3D (vol. thickness) from 40 to 200 mm
step 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 ms
TE = 25 ms
TI from 20 ms to 200 ms, step 5 ms
FA = 90°
minimum FOV 130 mm
minimum 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 ms
TE fixed at 26 ms
minimum FOV 100 mm
minimum slice thickness 2.0 mm | |
| | | High Resolution se_26_hf:
TR from 60 ms to 5000 ms, step 10 ms
TE fixed at 26 ms | |
| Characteristics | Artoscan C
K010057 | C-scan | Comments |
| | | minimum FOV 100 mm
minimum slice thickness 2.0 mm | with TE=26 msec.
High Resolution se_26_hf:
it is a Spin Echo T1 Half
Fourier sequence with
TE=26 msec. |
| | | High Resolution se_18_he
TR from 60 ms to 5000 ms, step 10 ms
TE fixed at 18 ms
minimum FOV 120 mm
minimum slice thickness 2.0 mm | High Resolution se_18_he:
it is a Spin Echo T1 Half
Echo sequence with TE=18
msec. |
| | | High Resolution tse_80:
TR from 200 ms to 5000 ms, step 10 ms
TE fixed at 80 ms
minimum FOV 120 mm
minimum slice thickness 3.0 mm | High Resolution tse_80: it
is a Turbo Spin Echo T2
sequence with TE=80 msec.
High Resolution tme: it is
the high resolution version
of the standard sequence |
| | | High Resolution tme:
TR from 200 ms to 5000 ms, step 10 ms
TE: first echo 28 ms, second echo 90 ms
minimum FOV 120 mm
minimum slice thickness 3.0 mm | Turbo Multi-echo.
High Resolution ge_16: it is
a Gradient Echo sequence
with TE=16 msec.
All the high resolution
sequences are already
present on E-scan XQ |
| | | High Resolution ge_16:
TR from 35 ms to 5000 ms, step 5 ms
TE fixed at 16 ms
FA from 10° to 90°, step 5°
minimum FOV 130 mm
minimum slice thickness 2 mm | K032121. |
| Acquisition Matrix: | 2D FT: from 192x 128 to
256x256; phase encoding step 8 | 2D FT for non High Resolution: from 192x
128 to 256x256; phase encoding step 8
2D FT for High Resolution: from 192x 128
to 512x512; frequency encoding step 32,
phase encoding step 8
3D FT: from 192x128 to 256x256; slice | To perform High resolution
sequences is necessary that
the raw data matrix
dimensions are increased
i.e. it's necessary to
increase the number of
readout (frequency) |
| Characteristics | Artoscan C
K010057 | 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. |
| Spatial
Resolution: | 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 |
3
4
ST
:
5
Gradients System
| Characteristics | Artoscan C
K010057 | C-scan | Comments |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Control System: | Digital, based on DSP SHARC
21062 @ 40 MHz, 80 MFLOPs,
with 256 KB On-Chip SRAM 3
independent channels (X-Y-Z)
DAC 18 bit - updating every 7.2
μs
Hardware ramp generation –
hardware pre-emphasis of eddy
current compensation | Digital electronic, based on DSP SHARC
21161@100 MHz, 400 MFLOPs, 128 KB
On-Chip SRAM
3 independent channels (X-Y-Z)
DAC 18 bit – update every 7.2 μs
Software ramp generation - software pre-
emphasis of eddy current suppression | The new control system is
described in the section
"Device Modification
Description" |
| Magnetic
compensation
system: | "open loop" control of the
magnetic field variation with
external measurement (AC and
DC probes); digital elaboration
of the signal in separated
channels (50/60 Hz - 16.6. Hz)
Digital electronic based on
microcontroller HC11 | "open loop" control of the magnetic field
variation with external measurement (AC
and DC probes); digital elaboration of the
signal in separated channels (DC - 50/60 Hz
- 16.6. Hz.
Digital electronic, based on DSP SHARC
21161@100 MHz, 400 MFLOPs, 128 KB
On-Chip SRAM | Technological updating.
A more detailed description
is in the the section "Device
modification description". |
·
26
.
・
6
Radiofrequency System
| Characteristics | Artoscan C
K010057 | C-scan | Comments |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| A/D Conversion: | baseband conversion and
demodulation of the RF received
signal in phase and quadrature
components
2 A/D converter 16 bit 78 kHz
sampling
2 digital low-pass filter for
analogical phase and quadrature
components; bandwidth: gain 1
up to 0.464xfc, con fc = 78.125
KHz/n, n=1+10; stop-band: from
0.5xfc; attenuation 90 dB. | For each channel:
3 MHz conversion of the RF received signal
A/D converter 14 bit 20 MHz sampling
digital demodulation in phase and quadrature
components
digital low-pass filter; bandwidth: gain 1 up
to 0.43 x fc, with fc from 156.25 to 4.882
kHz; stop-band: from 0.5 x fc; attenuation 90
dB.
Transferring to DSPM of raw data real and
imaginary parts. | Technological updating.
A more detailed decription
is in the the section "Device
modification description". |
| Synthesizer: | digital, through DSP SHARC 66
Mips, 132 MFlops, 0.5 Mbit
Memory on the chip, with
frequency, amplitude and phase
modulation
resolutions: 1,2 Hz frequency,
256 levels amplitude, 1°.4 phase
stability :