(35 days)
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.
The E-scan XQ is a magnetic resonance (MR) system. The modified system is composed of a patient positioning table, magnetic unit, operating console (PC unit, keyboard, mouse, monitor, operating table), electronics box with filter panel, and modular shielding box. The modifications from the cleared version (K020164) include a modified system configuration, new operating tables, upgrading of the electronics, and a new software release. These modifications are stated to not affect the intended use or alter the fundamental scientific technology of the device.
This document is a 510(k) premarket notification for modifications made to the E-Scan XQ MRI system. It's not a study report proving a device meets acceptance criteria through clinical or technical performance testing with a specific outcome measure like diagnostic accuracy. Instead, it demonstrates substantial equivalence to a previously cleared device (E-Scan XQ K020164) based on similar technological characteristics and unchanged intended use.
Therefore, many of the requested categories (acceptance criteria, reported performance, sample size, ground truth, expert consensus, MRMC study, standalone performance) are not applicable (N/A) in the context of this type of submission. The comparison is primarily against the specifications of the predicate device, not clinical performance metrics against a defined standard.
However, I can extract the information provided regarding the modification and the comparison to its predicate.
Here's a summary of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) amendment for modifications, the "acceptance criteria" are implicitly the maintenance of, or improvement upon, the technological characteristics of the predicate device, while ensuring the intended use is not altered. The "reported device performance" is a comparison of the modified device's technical specifications against the predicate.
| Characteristic | Predicate Device (E-scan XQ K020164) | Modified Device (E-scan XQ modified) | Acceptance / Performance Comment |
|---|---|---|---|
| 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 (Meets acceptance criterion of maintaining existing imaging capabilities) |
| Sequence Parameters (High Res) | Not explicitly detailed as "High Resolution" sequences with fixed TEs. | Added: High Resolution se_26 (TE=26ms), se_26_hf (TE=26ms), se_18_he (TE=18ms), tse_80 (TE=80ms), tse_50 (TE=50ms), tme (first echo 28ms, second echo 90ms), ge_16 (TE=16ms), ge_stir_25 (TE=25ms) | New feature/improved performance: These are particular versions of standard sequences with maximum acquisition matrix 512x512 (instead of 256x256 of non-High Resolution), aiming for best compromise between S/N and high resolution. This is an improvement. |
| Acquisition Matrix | 2D FT: 192x128 to 256x256; 3D FT: 192x128 to 256x256, slice encoding 24 to 128. | 2D FT for non High Resolution: 192x128 to 256x256; 2D FT for High Resolution: 192x128 to 512x512; 3D FT: 192x128 to 256x256, slice encoding 24 to 128. | Improved performance: Increased raw data matrix dimensions (up to 512x512 for High Resolution sequences) compared to the prior max of 256x256, allowing for higher resolution images. |
| Fringe Field (0.5 mT line) | X: 1.5 m front; 1.2 m rear; Y: 1.3 m; Z: 1.5 m | X: 1.34 m front; 1.06 m rear; Y: 1.25 m; Z: 1.29 m | More precise characterization of data (Specification update, not necessarily a performance change in itself, but implies refinement) |
| Gradients System - Control System | Digital, based on DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory; 1.1515 nsec Instruction rate; 4 independent channels (X - Y - Z - Bo); DAC 18 bit - updating every 7.2 µs. | 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. | Technological updating: Improved DSP (higher MFLOPs, increased memory) suggests potential for improved control and efficiency. |
| Magnetic Compensation System | Digital electronic based on DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory. | Digital electronic, based on DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM. | Technological updating: Improved DSP suggests potential for more robust magnetic field control. |
| A/D Conversion | Baseband conversion; 2 A/D converter 16 bit 78 kHz sampling; 2 digital low-pass filter (bandwidth up to 0.464xfc, fc = 78.125 KHz/n). | For each channel: 3 MHz conversion of RF signal; A/D converter 14 bit 20 MHz sampling; digital demodulation; digital low-pass filter (bandwidth up to 0.43 x fc, fc from 156.25 to 4.882 kHz). | Technological updating / Improved performance: Higher sampling rate (20 MHz vs 78 kHz) and different conversion method (3 MHz RF conversion vs baseband) indicates a significant upgrade in signal acquisition. |
| Synthesizer | Digital, through DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory; resolutions: 1.2 Hz frequency, 256 levels amplitude, 1°4° phase; stability < 1 ppm. | Digital, through DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM; resolutions: 28.4 µHz frequency, 4096 levels amplitude, 5'16" phase; stability < 1 ppm. | Technological updating / Improved performance: Significantly finer frequency, amplitude, and phase resolutions suggest a more precise and stable RF excitation. |
| Transmission Coil | Linear saddle shape coil; IN-impedance = 50 ohm; passive detuning during receiving through BYW29 diodes. | Linear saddle shape coil; IN-impedance = 50 ohm; active detuning during receiving through PIN diodes -5 V 100 mA. | Improved performance: Active detuning with PIN diodes avoids distortion of lateral lobes of the transmitting pulse, which was an issue with BYW29 diodes, leading to image quality enhancement. |
| Transmission Chain | RF power amplifier until 600 W pep; bandwidth 7-9 MHz; gain stability 0.1 dB. | RF power amplifier until 900 W pep; bandwidth 7-9 MHz; gain stability 0.1 dB. | Improved performance: Increased RF power amplifier output (900 W vs 600 W) allows for potentially faster or more robust excitation. |
| Central Processing Unit (CPU) | CPU Pentium III 850 MHz or faster; main memory: 256 MB; secondary cache: 256 KB or upper. | CPU Pentium IV 2.4 GHz or more; Main memory: 1 GB; Secondary cache: 512 KB or more. | Technological updating: Significant upgrade in CPU speed, main memory, and cache, indicating substantial improvement in processing power. |
| Control Processor | 36 MIPS, 72 MFlops, 0.25 MB memory. | DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + 384 KB SSRAM. | Technological updating: Improved DSP (higher MFLOPs, more memory) for control. |
| Acquisition & Reconstruction Processors | 36 MIPS, 72 MFlops, 0.5 MB memory + 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: Improved DSP and increased memory for acquisition and reconstruction. |
| 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: Increased hard disk capacity. |
| Image Reconstruction Matrix | 2D: 256x256; 3D: 256x256x8 to 256x256x128. | 2D: 128x128, 256x256, 512x512; 3D: 256x256x24 to 256x256x128. | Improved performance: Added 512x512 visualization matrix for high-resolution sequences. |
| Display Monitor | 19" CRT Colour OR 17" TFT Colour; 1280 x 1024 pixel; at least 70 Hz. | 18.1" TFT Color; 1280x 1024 pixel; not interleaved 60 Hz. | Technological updating: Updated monitor specification (specific TFT size, 60 Hz not-interlaced). |
| Patient Table Cushion Material | Wild Heather Ambla (DBL) foamed PVC on a fire retardant cotton support. | Coverlim 27 New (LIMONTA) 56% Cotton 44% Polyurethane. | Biocompatibility: New material evaluated as part of "Biocompatibility Summary" (not detailed in this section but mentioned). Maintaining safety requirements. |
| Vibrations | < -70 dBg da 0 a 100 Hz. | < -65 dBg from 0 to 100 Hz; warning range with standard feets: 9-13 Hz; warning range with vibration-damping springs: 4-7 Hz. | Improved adaptability/performance: Optional vibration-damping springs can lower magnet resonance frequency (from 11 Hz to 5.9 Hz) to enhance image quality in sites with significant vibrations (9-13 Hz range), by reducing ghost artifacts caused by magnetic field variations. |
| Power Consumption | 1100 VA (quick heating); 800 VA (normal working); 200 VA (powered off). | 1000 VA (quick heating); 800 VA (normal working); 200 VA (powered off). | More precise characterization of the data (Slight reduction in quick heating power, likely an optimization). |
| Shielding Box | Made of Fe or Al. | Only Al version available. | Product streamlining/update: Fe shielding box no longer available. (Assumed that Al version meets shielding requirements). |
| DICOM server/visualizer | ESA-VIEW Rel. 1. | ESA-VIEW Rel.2. | Technological updating: Updated software version. The ESA-VIEW Rel.2 is a cleared DICOM server/visualizer (K012093), ensuring continued compliance and functionality. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a 510(k) for device modifications, not a clinical study. The changes relate to hardware and software upgrades, and their impact is assessed through engineering analysis and comparison to the predicate device's established performance specifications, not a test set of images or patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. No test set requiring expert ground truth was mentioned for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set was mentioned.
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
N/A. This submission predates widespread AI integration in medical devices and is focused on hardware/software upgrades of an MRI scanner, not diagnostic AI performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. The "ground truth" for this engineering submission is compliance with established technical specifications and demonstration of substantial equivalence to the predicate device without altering the fundamental scientific technology or intended use.
8. The sample size for the training set
N/A. This is a medical device modification notification, not a machine learning model.
9. How the ground truth for the training set was established
N/A. Not applicable as above.
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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 Correspondent8000 Castleway DriveIndianapolis, 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 |
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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.
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Technological Characteristics
Comparison to the cleared device E-scan XQ K020164
Imaging system
| Characteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
|---|---|---|---|
| Pulse sequences | Orthogonal Multi-planar ScoutSpin 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 TurboME (tse, tme)Gradient Echo (ge)Short Time Inversion RecoveryGradient Echo (ge_stir)Gradient Echo 3D (t3d_t1)Gradient Echo 3D contrastenhancement (3d_ce)Real Time | Orthogonal Multi-planar ScoutSpin 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 |
| Sequenceparameters | 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 mmHigh Resolution se_26_hf:TR from 60 ms to 5000 ms, step 10 msTE fixed at 26 msminimum FOV 100 mmminimum slice thickness 2.0 mm | The high resolution sequences are aparticular version of the E-scan XQstandard sequences with maximumacquisition matrix 512x512 instead of256x256. All these sequences have afixed TE for obtaining the bestcompromise between the S/N and thehigh resolution.High Resolution se_26: it is a Spin EchoT1 sequence with TE=26 msec. | |
| Characteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
| High Resolution se_18_heTR from 60 ms to 5000 ms, step 10 msTE fixed at 18 ms | High Resolution se_26_hf: it is a SpinEcho T1 Half Fourier sequence withTE=26 msec. | ||
| minimum FOV 120 mmminimum slice thickness 2.0 mmHigh Resolution tse_80:TR from 200 ms to 5000 ms, step 10 msTE fixed at 80 ms | High Resolution se_18_he: it is a SpinEcho T1 Half Echo sequence withTE=18 msec. | ||
| minimum FOV 120 mmminimum slice thickness 3.0 mmHigh Resolution tse_50: | High Resolution tse_80: it is a TurboSpin Echo T2 sequence with TE=80msec. | ||
| TR from 200 ms to 5000 ms, step 10 msTE fixed at 50 msminimum FOV 120 mmminimum slice thickness 3.0 mm | High Resolution tse_50: it is the highresolution version of the standardsequence Turbo Spin Echo T2, TE=50ms. | ||
| High Resolution tme:TR from 200 ms to 5000 ms, step 10 msTE: first echo 28 ms, second echo 90 msminimum FOV 120 mm | High Resolution tme: it is the highresolution version of the standardsequence Turbo Multi-echo. | ||
| minimum slice thickness 3.0 mmHigh 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 | High Resolution ge_16: it is a GradientEcho sequence with TE=16 msec. | ||
| High Resolution ge_stir_25:TR from 150 ms to 5000 ms, step 10 msTE fixed at 25 msminimum FOV 130 mmminimum slice thickness 3 mm | High Resolution ge_stir_25: it is thehigh resolution version of the standardsequence Gradient Echo STIR, TE=25ms. | ||
| Characteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
| Acquisition Matrix: | l 2D FT: from 192x 128 to256x256; phase encoding step 8l 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 pl to 256x256; phase encoding step 812D FT for High Resolution: from 192x 128 to 512x512; frequency encoding step 32, phaseencoding step 8FT: from 192x128 to 256x256; slice p3Dencoding 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 ofreadout (frequency) sampling points and the number of phase encoding steps. |
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| Magnetic System | |||
|---|---|---|---|
| Characteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
| Fringe Field (0,5mT line): | X direction (horizontal) : 1,5 m front; 1,2 rearY direction (vertical) : 1,3 mZ direction (horizontal right/left):1.5 m | X direction (horizontal) : 1,34 m front; 1,06 rearY direction (vertical) : 1,25 mZ direction (horizontal right/left): 1,29 m | More precise characterization of the data |
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| Gradients System | |||
|---|---|---|---|
| Characteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
| Control System: | Digital, based on DSP SHARC 66Mips, 132 MFlops, 0.5 MbitMemory on the chip1.1515 nsec Instruction rate4 independent channels (X - Y - Z- Bo)DAC 18 bit - updating every 7.2µsRamp generation - preemphasis ofeddy current compensation -adjustable delay | Digital electronic, based on DSP SHARC21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM4 independent channels (X,Y,Z, Bo)DAC 18 bit - update every 7,2 µsRamp generation -- pre-emphasis of eddy currentsuppression - adjustable delay | Technological updating |
| Magneticcompensationsystem: | "open loop" control of themagnetic field variation withexternal measurement (AC and DCprobes); digital elaboration of thesignal in separated channels (DC -50/60 Hz - 16.6. Hz) andcorrection with Bo coil.Digital electronic based on DSPSHARC 66 Mips,132 MFlops, 0.5Mbit Memory on the chip | "open loop" control of the magnetic fieldvariation with external measurement (AC andDC probes); digital elaboration of the signal inseparated channels (DC - 50/60 Hz - 16.6. Hz)and correction with Bo coil.Digital electronic, based on DSP SHARC21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM | Technological updating |
| Characteristics | E-scan XQK020164 | E-scan XQmodified | 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 1 upto 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 up to0.43 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 thesection "Device modificationdescription". |
| Synthesizer: | digital, through DSP SHARC 66Mips, 132 MFlops, 0.5 MbitMemory on the chip, withfrequency, amplitude and phasemodulationresolutions: 1,2 Hz frequency, 256levels amplitude, 1' 4º phasestability : < 1 ppm into theoperative temperature rangetransmission variable gain: 256levels | digital, through DSP SHARC 21161@100 MHz,400 MFLOPs, 128 KB On-Chip SRAM, withfrequency, amplitude and phase modulationresolutions: 28.4 µHz frequency, 4096 levelsamplitude, 5' 16 " phasestability : < 1 ppm into the operative temperaturerangetransmission variable gain: 256 levels | Technological updating |
| TransmissionCoil: | linear saddle shape coilIN-impedance = 50 ohmpassive detuning during receivingthrough BYW29 diodes | linear saddle shape coilIN-impedance = 50 ohmactive detuning during receiving through PINdiodes -5 V 100 mA | The diodes, detuning the transmitting coil to theNMR frequency during the reception, avoid thatthe transmitting coil could receive partially theNMR signal. On the other hand the lateral lobesof the transmitting pulse are distorted by theBYW29 diodes.This effect is avoided with the introduction of thePIN diodes. |
| Transmissionchain: | RF power amplifier until 600 Wpepbandwidth 7÷9 MHzgain stability 0.1 dB | RF power amplifier until 900 W pepbandwidth 7÷9 MHzgain stability 0.1 dB | The modifications of the RF amplifierare described in the section "Devicemodification description". |
| Image Processing and Display System | Comments | ||
| Characteristics | E-scan XQ | E-scan XQ | |
| K020164 | modified | ||
| CentralProcessing Unit | ISA and PCI BusCPU Pentium III 850 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 |
| Control processor | 36 MIPS, 72 MFlops, 0.25 MBmemory | DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KBOn-Chip SRAM + 384 KB SSRAM | Technological updating |
| Acquisition andreconstruction | 36 MIPS, 72 MFlops, 0.5 MBmemory + 128 MB DRAM | DSP SHARC 21161@100 MHz, 400 MFLOPs,128 KB On-Chip SRAM + from 256 to 512 MBSDRAM + 1.28 MB SSRAM | Technological updating |
| processor: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 256x256x128step 8 | 2D: 128x128, 256x256, 512x5123D: 256x256x24 to 256x256x128 step 8 | The visualization matrix of the imagesobtained by the high resolutionsequences can be 128x128, 256x256 or512x512 pixels. |
| Display monitor | 19" CRT Colour17" TFT Colour1280 x 1024 pixelat least 70 Hz. not-interleavedhigh contrast | 18.1" TFT Color1280x 1024 pixelnot interleaved 60 Hzhigh contrast | Technological updating |
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Image Processing and Display System
{9}------------------------------------------------
| Patient positioning | E-scan XQ | E-scan XQ | Comments |
|---|---|---|---|
| Characteristics | K020164 | modified | |
| Cushion of therotating portion of thePatient Table | Composition of the materialcovering the cushion:Wild Heather Ambla (DBL)foamed PVC on a fire retardantcotton support | Composition of the material covering thecushion:Coverlim 27 New (LIMONTA) 56% Cotton44% Polyurethane | The evaluation of the new material is described inthe section "Biocomaaptibility Summary". |
・
・
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| Characteristics | E-scan XQK020164 | Installation Area ConditionsE-scan XQmodified | Comments |
|---|---|---|---|
| Vibrations: | < -70 dBg da 0 a 100 Hz | < -65 dBg from 0 to 100 Hzwarning range with standard feets: 9÷13 Hzwarning range with vibration-damping springs:4÷7 Hz | The vibration-damping springs can be used,instead of the standard feets, to install the systemin sites with important vibrations in the frequency ofrange 9 ÷13 Hz for lowering the resonancefrequency of the magnet from 11 Hz to 5.9 Hz.The final effect is the image quality enhancementfrom the artifacts point of view, as themechanical vibrations cause a variation of themagnetic field intensity and consequently ghostartifacts on the images. |
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and the control control control control control controllers and
{11}------------------------------------------------
| Power supply | Comments | ||
|---|---|---|---|
| Characteristics | E-scan XQK020164 | E-scan XQmodified | |
| Powerconsumption: | 1100 VA during quick magnetheating800 VA during normal working200 VA when unit is powered off(thermal control on) | 1000 VA during quick magnet heating800 VA during normal working200 VA when unit is powered off (thermalcontrol on) | More precise characterization of the data |
:
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.
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| Dimensions and weightsCharacteristics | E-scan XQK020164 | E-scan XQmodified | Comments |
|---|---|---|---|
| Composition ofthe device | Magnetic Unit with PatientPositioning tableConsole | Magnetic Unit with Patient Positioning tableElectronic boxOperating Table with Personal Computer | The new composition is described in thesection "Device ModificationDescription". |
| Console: | Width 0.844 m; Depth 0.940 m;Height 0.735 m;Weight 150 Kg | Not available | |
| Electronics box: | Not available | Width 0.793 m; Depth 0.632 m; Height 1.563m;Weight 150 Kg | The electronics box is described in thesection "Device modificationdescription". |
| PersonalComputer: | Not available | Width 26 cm; Depth 44 cm; Height 43 cm;Weight 15 Kg | The PC is described in the section"Device modification description". |
| Accessories | E-scan XQ | Comments | |
| Characteristics | E-scan XQ | modified | |
| K020164 | |||
| Operating table: | Not available | Available in two modelsHigh version: width 108 cm; depth 88 cm;height 74 cm;weight: 78 kgComfort version: width 108 cm; depth 80 cm;height 74 cm;weight: 59 kg | The operating tables are described in thesection "Device modificationdescription". |
| Shielding box | Shielding box made of Feattenuation:RF 70 dBDC magnetic field 1.0AC 16.6 Hz magnetic field 1.5AC 50/60 Hz magn. field 2.6weight: 1300 KgShielding box made of Alattenuation:RF 70 dBDC magnetic field 1.0AC 16.6 Hz magnetic field 1.8AC 50/60 Hz magn. field 4.0weight: 500 Kg | Shielding box made of Alattenuation:RF 70 dBDC magnetic field 1.0AC 16.6 Hz magnetic field 1.8AC 50/60 Hz magn. field 4.0weight: 500 Kg | The Shielding Box made of Fe is notavailable any more. |
| DICOMserver/visualizerdedicated to PC | ESA-VIEW Rel. 1 | ESA-VIEW Rel.2 | ESA-VIEW Rel.2 is a DICOMserver/visualizer dedicated to PersonalComputers and is part of the DICOMedfamily of products. It is picture archivingand communications system softwarethat provides acquisition, storage,transfer, and display of medical imagedata.The DICOMed family is a class II devicein accordance with 21CFR892.2050 -Federal Register 01/04/01 and wascleared via K012093. |
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Note: Any deviations from original E-scan XQ specifications are substantiated within Quality System documentation at Essacte S.p.A.
.
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2003
Esaote, S.p.A. % Ms. Colleen J. Densmore The Anson Group LLC 7992 Castleway Drive INDIANAPOLIS IN 46250
Re: K032121
Trade/Device Name: E-Scan XQ MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: July 8, 2003 Received: July 14, 2003
Dear Ms. Densmore:
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 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): K1032121
Device Name:
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 portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ 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), 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.
Prescription Use ✓
David A. Ingram
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.