(35 days)
Not Found
No
The document describes a standard MR system with hardware and software updates, but there is no mention of AI or ML capabilities in the intended use, device description, or any other section. The focus is on image acquisition and display for interpretation by a medical expert.
No.
The device is used to produce images for diagnostic information, not to treat a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This indicates that the device produces information used for diagnosis.
No
The device description explicitly lists multiple hardware components including a patient positioning table, magnetic unit, operating console (PC unit, keyboard, mouse, monitor, operating table), electronics box, and modular shielding box. While it includes a new software release, it is part of a larger hardware system.
Based on the provided information, the E-scan XQ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- E-scan XQ Function: The E-scan XQ is a Magnetic Resonance (MR) system. It produces images of the limbs and joints within the living body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "imaging the arm... and imaging the leg..." and that the images "can provide diagnostically useful information" when interpreted by a medical expert. This describes an imaging modality used for diagnosis based on visualizing internal structures, not analyzing biological samples.
Therefore, the E-scan XQ falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nucle) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice 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.
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
The E-scan XQ device is a magnetic resonance (MR) system designed to produce images of the limbs and joints. The modifications on this version of the E-scan XQ, relative to the cleared version K020164, are primarily for system performance improvement and do not affect the intended use or alter the fundamental scientific technology. The modifications include:
- Modified system configuration: The previous console, which combined the operating console (mouse, keyboard, monitor, ODD, FDD, CD-RW) and the Electronics box, has been separated. The modified system now features an operating console consisting of a PC unit (with keyboard and mouse), monitor, and operating table, alongside a separate Electronics box with a filter panel, and a modular shielding box.
- New operating tables: Two models are available: a high version (width 108 cm; depth 88 cm; height 74 cm; weight: 78 kg) and a comfort version (width 108 cm; depth 80 cm; height 74 cm; weight: 59 kg).
- Upgrading of the electronics: This includes technological updates to various components:
- Control System: Upgraded to DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM, with 4 independent channels (X, Y, Z, Bo).
- Magnetic Compensation System: Uses DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM for digital elaboration of signals.
- A/D Conversion: Features 3 MHz conversion of RF signal, 14-bit 20 MHz sampling A/D converter, digital demodulation, and digital low-pass filters with a wider range of fc.
- Synthesizer: Upgraded DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM, offering higher frequency and amplitude resolutions.
- Transmission Coil: Now uses active detuning through PIN diodes during receiving to avoid signal distortion.
- Transmission Chain: RF power amplifier upgraded to 900 W pep.
- A new software release: This includes new high-resolution pulse sequences:
- High Resolution se_26: Spin Echo T1 sequence with TE=26 ms.
- High Resolution se_26_hf: Spin Echo T1 Half Fourier sequence with TE=26 ms.
- High Resolution se_18_he: Spin Echo T1 Half Echo sequence with TE=18 ms.
- High Resolution tse_80: Turbo Spin Echo T2 sequence with TE=80 ms.
- High Resolution tse_50: Turbo Spin Echo T2 sequence with TE=50 ms.
- High Resolution tme: Turbo Multi-echo sequence.
- High Resolution ge_16: Gradient Echo sequence with TE=16 ms.
- High Resolution ge_stir_25: Gradient Echo STIR sequence with TE=25 ms.
- These high resolution sequences increase the acquisition matrix to 512x512 pixels.
- The DICOM server/visualizer has been updated to ESA-VIEW Rel.2.
The core components remain: patient positioning table, magnetic unit, and the console/electronics. The shielding box now solely refers to the Aluminum version.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Limbs and joints, specifically:
- Arm: hand, wrist, forearm, elbow, upper arm, shoulder
- Leg: foot, ankle, calf, knee, thigh, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert trained in the use of MR equipment.
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.
K020164, K963262, K990968, K001894, K012728
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.
Not Found
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
K032/2/
AUG 1 3 2003
510(k) Summary E-Scan XQ Biosound Esaote
510(k) Summary
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: | Colleen Densmore | |
| Date: | June 30, 2003 | |
| 807.92(a)(2) | ||
| Trade Name: | E-Scan XQ | |
| 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 M | K963262 |
| Esaote | E-Scan | K990968 |
| Esaote | E-Scan | K001894 |
| Esaote | Hip Coil | K012728 |
| Esaote | E - Scan XQ | K020164 |
1
01.92(a)(4)
Device Description
Summary of E-scan XQ modifications
The changes performed on the E-scan XQ device, with respect to the cleared version - E-scan XQ K020164 -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.
-
- Modified system configuration.
-
- New operating tables.
- Upgrading of the electronics. งา
-
- A new software release.
System configuration
Unmodified E-scan XQ
The unit is composed of these main parts:
- 1 Patient positioning table.
-
- Magnetic unit.
- Console, made of the Operating console (mouse, keyboard, monitor, ODD, FDD and CD-RW) and the 3. Electronics box.
- Modular shielding box with filter panel. 4.
Modified E-scan XQ
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the 3. operating table.
-
- Electronics box with filter panel.
- ഗ Modular shielding box.
807.92(a)(5)
Intended Use(s)
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nucle) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice 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.
2
Technological Characteristics
Comparison to the cleared device E-scan XQ K020164
Imaging system
| Characteristics | E-scan XQ
K020164 | E-scan XQ
modified | Comments |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse sequences | Orthogonal Multi-planar Scout
Spin Echo T1 (set1)
Spin Echo T2 (set2)
Multi-Echo (se_pd_t2)
Inversion Recovery (ir)
Short TI Inversion Recovery (stir)
Spin Echo Half Echo (set1he)
Spin Echo Half Scan (set1hf)
Turbo SE T2 weighted and Turbo
ME (tse, tme)
Gradient Echo (ge)
Short Time Inversion Recovery
Gradient Echo (ge_stir)
Gradient Echo 3D (t3d_t1)
Gradient Echo 3D contrast
enhancement (3d_ce)
Real Time | Orthogonal Multi-planar Scout
Spin Echo T1 (set1)
Spin Echo T2 (set2)
Multi-Echo (se_pd_t2)
Inversion Recovery (ir)
Short TI Inversion Recovery (stir)
Spin Echo Half Echo (set1he)
Spin Echo Half Scan (set1hf)
Turbo SE T2 weighted and Turbo ME (tse, tme)
Gradient Echo (ge)
Short Time Inversion Recovery Gradient Echo
(ge_stir)
Gradient Echo 3D (t3d_t1)
Gradient Echo 3D contrast enhancement (3d_ce)
Real Time | Unchanged |
| Sequence
parameters | | 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
minimum FOV 100 mm
minimum slice thickness 2.0 mm | The high resolution sequences are a
particular version of the E-scan XQ
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 with TE=26 msec. |
| Characteristics | E-scan XQ
K020164 | E-scan XQ
modified | Comments |
| | | High Resolution se_18_he
TR from 60 ms to 5000 ms, step 10 ms
TE fixed at 18 ms | High Resolution se_26_hf: it is a Spin
Echo T1 Half Fourier sequence with
TE=26 msec. |
| | | minimum FOV 120 mm
minimum slice thickness 2.0 mm
High Resolution tse_80:
TR from 200 ms to 5000 ms, step 10 ms
TE fixed at 80 ms | High Resolution se_18_he: it is a Spin
Echo T1 Half Echo sequence with
TE=18 msec. |
| | | minimum FOV 120 mm
minimum slice thickness 3.0 mm
High Resolution tse_50: | High Resolution tse_80: it is a Turbo
Spin Echo T2 sequence with TE=80
msec. |
| | | TR from 200 ms to 5000 ms, step 10 ms
TE fixed at 50 ms
minimum FOV 120 mm
minimum slice thickness 3.0 mm | High Resolution tse_50: it is the high
resolution version of the standard
sequence Turbo Spin Echo T2, TE=50
ms. |
| | | 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 | High Resolution tme: it is the high
resolution version of the standard
sequence Turbo Multi-echo. |
| | | minimum slice thickness 3.0 mm
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 | High Resolution ge_16: it is a Gradient
Echo sequence with TE=16 msec. |
| | | High Resolution ge_stir_25:
TR from 150 ms to 5000 ms, step 10 ms
TE fixed at 25 ms
minimum FOV 130 mm
minimum slice thickness 3 mm | High Resolution ge_stir_25: it is the
high resolution version of the standard
sequence Gradient Echo STIR, TE=25
ms. |
| Characteristics | E-scan XQ
K020164 | E-scan XQ
modified | Comments |
| Acquisition Matrix: | l 2D FT: from 192x 128 to
256x256; phase encoding step 8
l 3D FT: from 192x128 to 256x256;
l slice encoding from 24 to 128,
l step 8; phase encoding step 8 | 2D FT for non High Resolution: from 192x 128 To perform High resolution sequences is p
l to 256x256; phase encoding step 8
12D FT for High Resolution: from 192x 128 to
512x512; frequency encoding step 32, phase
encoding step 8
FT: from 192x128 to 256x256; slice p
3D
encoding from 24 to 128, step 8; phase encoding ,
step 8 | that the raw data matrix ,
necessary
dimensions are increased, i.e. it's
necessary to increase the number of
readout (frequency) sampling points and
the number of phase encoding steps. |
3
4
5
| Magnetic System | |||
|---|---|---|---|
| Characteristics | E-scan XQ | ||
| K020164 | E-scan XQ | ||
| modified | Comments | ||
| Fringe Field (0,5 | |||
| mT line): | X direction (horizontal) : 1,5 m front; 1,2 rear | ||
| Y direction (vertical) : 1,3 m | |||
| Z direction (horizontal right/left): | |||
| 1.5 m | X direction (horizontal) : 1,34 m front; 1,06 rear | ||
| Y direction (vertical) : 1,25 m | |||
| Z direction (horizontal right/left): 1,29 m | More precise characterization of the data |
the submit was an a submit and the submit of the subsequence is a
6
| Gradients System | |||
|---|---|---|---|
| Characteristics | E-scan XQ | ||
| K020164 | E-scan XQ | ||
| modified | Comments | ||
| Control System: | Digital, based on DSP SHARC 66 | ||
| Mips, 132 MFlops, 0.5 Mbit | |||
| Memory on the chip | |||
| 1.1515 nsec Instruction rate | |||
| 4 independent channels (X - Y - Z |
- Bo)
DAC 18 bit - updating every 7.2
µs
Ramp generation - preemphasis of
eddy current compensation -
adjustable delay | Digital electronic, based on DSP SHARC
21161@100 MHz, 400 MFLOPs, 128 KB On-
Chip SRAM
4 independent channels (X,Y,Z, Bo)
DAC 18 bit - update every 7,2 µs
Ramp generation -- pre-emphasis of eddy current
suppression - adjustable delay | Technological updating |
| 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 (DC -
50/60 Hz - 16.6. Hz) and
correction with Bo coil.
Digital electronic based on DSP
SHARC 66 Mips,132 MFlops, 0.5
Mbit Memory on the chip | "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)
and correction with Bo coil.
Digital electronic, based on DSP SHARC
21161@100 MHz, 400 MFLOPs, 128 KB On-
Chip SRAM | Technological updating |
| Characteristics | E-scan XQ
K020164 | E-scan XQ
modified | 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 | 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' 4º phase
stability :