(90 days)
Esaote Biomedica ArtoScan
Not Found
No
The description details standard MRI technology and image processing techniques from 1996, with no mention of AI or ML.
No.
The device description and intended use clearly state its purpose is for "2D imaging, 3D imaging" of "Extremities" using "Magnetic Resonance" technology, which is a diagnostic function, not therapeutic.
Yes
Explanation: The device is described as performing "2D imaging, 3D imaging" and producing "T1 weighted, T2 weighted, T2* weighted images" which are used for "investigation of Du Puytrens contracture of the hand localization of the calcaneus for steroid injections and scans of the normal anatomy". These are all diagnostic activities.
No
The device description clearly outlines hardware components such as magnets, RF coils, and a fixed site installation, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "2D imaging, 3D imaging" of "Extremities" using Magnetic Resonance technology. This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details the components and functionality of an MRI scanner (magnet, coils, pulse sequences, reconstruction techniques, etc.).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological specimens.
The device is clearly an in vivo diagnostic imaging device, specifically a Magnetic Resonance Imaging (MRI) system designed for imaging the extremities.
N/A
Intended Use / Indications for Use
Anatomical region : Extremities Nuclei excited Diagnostic uses : 2D imaging, 3D imaging
Product codes
Not Found
Device Description
A. Device Characteristics
Model Name : Ortho 8000
Isotope : Proton Imaging
Model Characteristics
Magnet Permanent
0.17 Tesla Static Field strength +/-20ppm over 16cm DSV Homogeneity
RF Coil Types
- Leg coil l Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length
-
- 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
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: 20:1 Transverse, Sagittal, Coronal, Oblique
Arm Coil: SNR > 40:1 Transverse, Sagittal, Coronal
18 cm Loop Coil: SNR > 30:1 Transverse, Sagittal, Coronal
12 cm Loop Coil: SNR > 30:1 Transverse, Sagittal, Coronal
Uniformity
Leg Coil: Non-Uniformity 80% of material within Full Width Half Maximum. See detailed plots. Transverse, Sagittal, Coronal
Slice Thickness
Arm coil: 2-10 mm in 1mm increments - Transverse, Sagittal, Coronal
Slice Spacing
Arm coil: 0 - 10 mm in 1mm increments - Transverse, Sagittal, Coronal
Simultaneous Slices
16 maximum
Spatial Resolution
Leg Coil: Maximum theoretical pixel resolution = 80/256 mm = 0.31 mm
1 mm test rods resolved in all 4 quadrants Transverse, Sagittal. Coronal.
Mentions image processing
Image Pre and Post Processing
Magnitude Value Pixel Value Horizontal/Vertical Line Profiles Spatial Filtering - Hamming Filter in Frequency and Phase Directions
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device
Anatomical Site
Extremities
knee/foot/ankle/leg/elbow
hand/wrist/forearm
toes, feet, ankles, lower leg, knee and upper thigh, fingers, hand, wrist, forearm. elbow and upper arm.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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
INNER VISION 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
+44 0802 791352 (Tel) Telephone Number : +44 1535 635066 (Fax)
( 1)
Contact Person : Dr Martyn Paley
Date Summary Prepared : 18th July 1996
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
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
0.17 Tesla Static Field strength +/-20ppm over 16cm DSV Homogeneity
RF Coil Types
- Leg coil l Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length
-
- 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 | 20:1 Transverse, Sagittal, Coronal, Oblique |
| 2 | Arm Coil |
| SNR > 40:1 Transverse, Sagittal, Coronal | |
| 3 | 18 cm Loop Coil |
| 4 | 12 cm Loop Coil |
| SNR > 30:1 Transverse, Sagittal, Coronal | |
| b. Uniformity | |
| 1 | Leg Coil |
| Non-Uniformity 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
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
I mm 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 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