← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K963186 # ORTHO 8000 (K963186) _Inner Vision Mri , Ltd. · LNH · Nov 12, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963186 ## Device Facts - **Applicant:** Inner Vision Mri , Ltd. - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Nov 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use Anatomical region : Extremities Nuclei excited : H-1 Diagnostic uses : 2D imaging, 3D imaging ## Device Story Ortho 8000 is a permanent magnet MRI system (0.17 Tesla) for extremity imaging. It uses RF coils (leg, arm, loop) to acquire H-1 proton signals via spin echo, gradient echo, and inversion recovery pulse sequences. Data is sampled in k-space and processed using 2D/3D Fourier transforms. The system is installed in fixed clinical sites and operated by trained personnel. Output consists of T1, T2, and T2* weighted images displayed on a monitor. Healthcare providers use these images to visualize anatomy and pathology (e.g., Du Puytrens contracture, localization for injections) to inform clinical diagnosis and treatment planning. ## Clinical Evidence Clinical evaluation performed at Middlesex Hospital, London (Feb-July 1996). Scans included investigation of Du Puytrens contracture, localization for steroid injections, and normal anatomy of extremities (fingers, hand, wrist, forearm, elbow, upper arm, toes, feet, ankles, lower leg, knee, upper thigh). Bench testing confirmed SNR >20:1 (leg/loop coils) and >40:1 (arm coil), non-uniformity <+/-20%, and geometric distortion <+/-5%. ## Technological Characteristics Permanent magnet (0.17T); 0.4 W/Kg max RF power; 6 T/s max dB/dt. RF coils: leg, arm, 12cm/18cm loop. Reconstruction: 2D/3D Fourier Transform. Connectivity: MOD/Tape storage, optional 3rd party DICOM. Power: 110/240V. Cooling: Air conditioning control +/- 1C. Software: 2x Pentium 100 MHz PCs, Dalanco Spry Model 500 DSP. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Esaote Biomedica ArtoScan ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} # INNERVISION MRI *Specialized MRI Systems for Medicine, Industry and Research* NOV 12 1996 ## FDA 510K Summary Submitter's Name: Dr Martyn Paley Postal Address: PO Box 8232, London, W5 3WY Telephone Number: +44 0802 791352 (Tel) +44 1535 635066 (Fax) Contact Person: Dr Martyn Paley Date Summary Prepared: 18th July 1996 ![img-0.jpeg](img-0.jpeg) K963186 INNERVISION MRI Ltd., PO Box 8232, London W5 3WY Directors: Martyn Paley BSc PhD CPhys FInstP, John McGinley BA DPhil MInstP IMRI/510KSUM/1/1/001 1 of 6 {1} 1. **DEVICE NAME**: Magnetic Resonance Diagnostic Device Trade/Proprietary Name: Ortho 8000 2. **EQUIVALENT DEVICE**: Esaote Biomedica ArtoScan 3. **DEVICE DESCRIPTION** A. **Device Characteristics** Model Name: Ortho 8000 Isotope: Proton Imaging Model Characteristics Magnet Permanent Static Field strength: 0.17 Tesla Homogeneity: +/-20ppm over 16cm DSV RF Coil Types 1. Leg coil Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length 2. Arm Coil Transmit/receive coil for hand/wrist/forearm 10 cm Diameter x 6 cm Length 3. 18 cm Loop Coil Transmit/receive coil for general purpose use 4. 12 cm Loop Transmit/receive coil for general purpose use Data Acquisition Modes Phase and frequency encoding to sample k-space 2D Multiple Slice 2D Multiple Slice, Multiple Echo 3D Multiple Slice Pulse Sequences Spin echo Gradient (Field) echo Inversion recovery Dynamic imaging These sequences can provide T1 weighted, T2 weighted, T2* weighted images Reconstruction Techniques 2D Fourier Transform IMRI/510KSUM/1/1/001 {2} 3D Fourier Transform Type of Installation Fixed Site Slice Selection Methods Selective excitation in the presence of a field gradient Phase encoding for 3D Display Matrix 256 x 256 1 - 4 Simultaneous Images Acquisition Matrix 64 - 256 in steps of 1 for the phase encoding direction 256 in the frequency encoding direction Image Acquisition Time 2D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps 3D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps x Number of Slice Encoding Steps Image Pre and Post Processing Magnitude Value Pixel Value Horizontal/Vertical Line Profiles Spatial Filtering - Hamming Filter in Frequency and Phase Directions Number of Slices, Range and Increment 2D - 1-16 in steps of 1 3D - 16 slice only Slice Orientation Transverse (Axial) Sagittal Coronal Oblique 3 Orthogonal Plane Scouts Interslice Spacing, minimum, maximum and increment 0 mm, 10mm, Increment 1 mm ## B Safety Parameters | Static Field Strength | 0.17 Tesla | | --- | --- | | Rate of change of magnetic field, maximum | < 6 Tesla/Second | | Radiofrequency Power Deposition, maximum | < 0.4 W/Kg | IMRI/510KSUM/1/1/001 {3} Acoustic Noise 80 dBA ## C. Imaging Performance ### Specification Volume 75mm length x 75 mm diameter Cylinder #### a. Signal to Noise Ratio (SNR) 1. Leg Coil SNR > 20:1 Transverse, Sagittal, Coronal, Oblique 2. Arm Coil SNR > 40:1 Transverse, Sagittal, Coronal 3. 18 cm Loop Coil SNR > 20:1 Transverse, Sagittal, Coronal 4. 12 cm Loop Coil SNR > 30:1 Transverse, Sagittal, Coronal #### b. Uniformity 1. Leg Coil Non-Uniformity < +/-20% Transverse, Sagittal, Coronal 2. Arm Coil Non-Uniformity < +/-20% Transverse, Sagittal, Coronal 3. 18 cm Loop Coil Non-Uniformity < +/-20% Transverse, Sagittal, Coronal 4. 12 cm Loop Coil Non-Uniformity < +/-20% Transverse, Sagittal*, Coronal #### c. Geometric Distortion Geometric Distortion < +/- 5% Transverse, Sagittal, Coronal #### d.1 Slice Profile Arm coil >80% of material within Full Width Half Maximum. See detailed plots. Transverse, Sagittal, Coronal #### d.2 Slice Thickness Arm coil IMRI/510KSUM/1/1/001 4 of 6 {4} 2-10 mm in 1mm increments - Transverse, Sagittal, Coronal d.3 Slice Spacing Arm coil 0 - 10 mm in 1mm increments - Transverse, Sagittal, Coronal Simultaneous Slices 16 maximum e Spatial Resolution Leg Coil Maximum theoretical pixel resolution = 80/256 mm = 0.31 mm. 1mm test rods resolved in all 4 quadrants Transverse, Sagittal, Coronal. Note : Performance parameters measured using the phantom and techniques described in Section 8B below. ## 4. INTENDED USE Anatomical region : Extremities Nuclei excited : H-1 Diagnostic uses : 2D imaging, 3D imaging ## 5. TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE See Appendix A ## 6. CLINICAL DATA Testing of the system was performed at the Middlesex Hospital, London, England during the period February - July 1996. Clinical scans performed included investigation of Du Puytrens contracture of the hand localisation of the calcaneus for steroid injections and scans of the normal anatomy of the toes, feet, ankles, lower leg, knee and upper thigh, fingers, hand, wrist, forearm, elbow and upper arm. ## 7. CONCLUSIONS FROM TESTING The measurement methods used are based on calibration using a well characterised physical object and provide direct evidence of the performance characteristics of the scanner. The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above. Non-uniformity was < +/- 20% for all coil and sequence combinations tested. Geometric distortion was < +/- 5% for all coil and sequence combinations tested. Slice thickness, spacing and gap were all within the quoted specifications using the frequency encoding method. This method relies on accurate calibration of the Field of View using MR imaging. The size of the test object is very accurately known and the measurement method provides a scale with 256 pixels. It is believed that this method gives more reliable results than the slice ramp technique which was also used to confirm the measurements. This is because the method has a much higher signal to noise ratio. IMRI/510KSUM/1/1/001 {5} In conclusion, the InnerVision MRI extremity scanner meets the performance specifications claimed. ## 8. OTHER INFORMATION REQUIRED BY FDA IMRI/510KSUM/1/1/001 6 of 6 {6} # Appendix A ## Equivalency Information This information has been obtained from a recent report by ECRI. IMRI/FDANICHE/1/1/001 {7} Appendix A Comparison of Esaote Artoscan and InnerVision Niche | Model | Esatote/Lunar Artoscan | Innervision/Vision Ortho 8000 | | --- | --- | --- | | Clinical application | Extremities | Extremities | | Magnet type | Permanent | Permanent | | Field Strength | 0.18T | 0.17T | | 5 Gauss Fringe Field m | 0.6/0.28 | 0.3/0.3 | | Shimming | Passive | Passive/Active | | Gradient Subsystem mT/m Risetime to 10mT/m msec | 10/0.5 | 15/0.5 | | Computer System | PC DX2, 66 | 2 x PC Pentium 100 MHz | | Memory Size (MB) | 32 | 16+16 | | Array Processor | DSP 25 Mflops | DSP Dalanco Spry Model 500 | | Storage Media | MOD | MOD, Tape | | No. Images Stored | 5,000 | 5,000 | | Imaging Modes | | | | Single | Yes | Yes | | MultiSlice | Yes | Yes | | Volume Study | Yes | Optional | | Other | 3 Plane Scout View | 3 Plane Scout View | | Reconstruction time | | | | Single Slice (sec) | 1.5 | 5 | | Multi Slice (sec) | 1.5 | 5 | | Volume Study | 1.5 | 20/slice average | | Cardiac Gating | NA | NA | | Respiratory Gating | NA | NA | | Angiography | NA | NA | | Spectroscopy | NA | NA | | Pulse Sequences | SE, Multiple SE, GE, IR, STIR, 3D, TSE, TME, HSE | SE, Multiple SE, GE, IR, STIR, 3D | | Repetition Time (msec) | 50-5000SE, 40-5000 GE, 260-5000 IR, 100-4000 STIR | 50-5000SE, 35-5000 GE, 100-5000 IR | | Echo Time (msec) | 18-120 SE, 12-34 GE, 18-34 IR, 12-120 TSE | 20-100 SE, 5 GE, 20 IR | | Inversion Time (msec) | 50-800 | 25-999 | | Slice Thickness mm | 2-10 0.5 incr 2D, 0.8 - 10 0.1 incr 3D | 2 - 10 1 incr 2D, 1-10 1 incr 3D | | FOV mm | 100 - 200 | 80 - 200 | | Displayed FOV | 110 max Increments of 10 | 200 max increments of 1 | | FOV offsets | NA | NA | | Scan Orientations | Transverse, coronal, sagittal, oblique, compound oblique | Transverse, coronal, sagittal, oblique | | Measuring Matrix | 128x128 to 256x256 2D 128x128x8 to 256x256x128 3D | 64x256 to 256x256 2D 64x256x16 to 256x256x16 3D incr 1 in phase | | Display Matrix | 254x238, 510x478 | 256x256, 512x512 | | Pixel Intensity | 0-4095 | 0.255 | | Spatial Resolution | 0.4 mm | 0.5 | | Coils | Knee 2 Sizes, Extremity | Arm Coil, Leg Coil, 12 cm Loop, 18 cm Loop | | Bore Diameter W x H cm | 16 x 33.6 | 20 x 75 | | Bore Features | Self centring mechanism, internal RF shield, Leg-locking device | Self centring mechanism | | Cooling System | Not required | Air Conditioning Control +/- 1C | | Cryogens | NA | NA | | Magnet Weight | 1000 | 500 | | HxWxD cm | 120x73x52 | 118x51x52 | | Dicom 3.0 | Optional | From 3rd Party | | Power Requirements | | | | Line Voltage | 110 | 110/240 | | kVA | 1.3 | <3 | | AC BTU | 4500 | <10,000 | | Sitting Requirement ft2 | <100 | <100 | | RF shielding | Integral | Modular screened room | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963186](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963186) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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