← Product Code [LHN](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/LHN) · K981358
# ARTOSCAN S (K981358)
_Biosound Esaote, Inc. · LHN · Jul 13, 1998 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/LHN/K981358
## Device Facts
- **Applicant:** Biosound Esaote, Inc.
- **Product Code:** [LHN](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/LHN.md)
- **Decision Date:** Jul 13, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Indications for Use
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
## Device Story
Artoscan S is a dedicated extremity MRI system using a 0.18 T permanent Neodymium alloy magnet. It captures MR signals from limbs (hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist, hand) via solenoidal or DPA receiver coils. The system transforms these signals into cross-sectional images (transverse, sagittal, coronal, oblique) based on proton density and relaxation times (T1, T2). Operated by clinicians in a fixed installation, the device features a large gantry opening to reduce patient claustrophobia. Output images are displayed on a 17-inch monitor and used by physicians to visualize internal limb structures for diagnostic purposes. The system supports DICOM3 networking for printing and image transmission.
## Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, technical specifications, and comparison of imaging parameters (e.g., pulse sequences, gradient strength, FOV) against predicate devices.
## Technological Characteristics
0.18 T 'C'-shaped Neodymium alloy permanent magnet; 20 mT/m gradient strength; 0.5 msec rise time; solenoidal and DPA (quadrature) receiver coils; DICOM3 connectivity; Pentium 200 MHz CPU; 32 MB RAM; 2.6 GB hard disk; 640 MB optical disk; self-contained RF shielding.
## Regulatory Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
## Predicate Devices
- Esaote Artoscan M ([K963262](/device/K963262.md))
- Hitachi AIRIS ([K945155](/device/K945155.md))
- Elscint PRIMA 1TG ([K970990](/device/K970990.md))
## Submission Summary (Full Text)
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{0}------------------------------------------------
# JUL 1 3 1898
K981358
Safety and Effectiveness Summary Artoscan S Biosound Esaote
# Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to The following surcey and commaries specified in 21CFR 807.92(a).
807.92(a)(1)
# Submitter Information
Submitter Information
| Colleen Hittle, Official Correspondent |
|----------------------------------------|
| 8000 Castleway Drive |
| Indianapolis, IN 46250 |
| Phone: | (317) 849-1916 |
|------------|----------------|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
|-----------------|----------------|
| Date: | March 25, 1998 |
807.92(a)(2)
FDA/CDRH/ODE/DMC
14 APR 98 09 57
Artoscan S Trade Name: Magnetic resonance diagnostic device Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s):
90LNH Classification Number:
807.92(a)(3)
| Esaote | Artoscan M | K963262 |
|---------|------------|---------|
| Hitachi | AIRIS | K945155 |
| Elscint | PRIMA 1TG | K970990 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
Predicate Device(s)
{1}------------------------------------------------
#### Imaging System 1.
ERR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
,在
| Characteristic | ARTOSCAN S | AIRIS
K945155 | Comments |
|----------------|---------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Clinical use | Knee, leg, ankle, foot,
hand, wrist, forearm,
elbow, shoulder, hip. | Whole body, central
nervous system and
orthopaedic regions. | Two new joints
(hip and
shoulder) have
been introduced
for examination. |
| Field of view | From 100 up to 300 mm,
step 10 mm (140 mm are
displayed). | From 50 up to 350 mm in
diameter. | A larger FOV
has been realized
to better cover
the anatomical
parts to be
imaged. |
#### 1. Magnetic System
| Characteristic | ARTOSCAN S | AIRIS
K945155 | Comments |
|---------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------|
| Type of magnet | "C" shaped Neodymium
alloy permanent magnet. | "C" shaped Neomax™
(Neodymium alloy)
permanent magnet. | |
| Static field
strength | 0.18 T (perpendicular to
patient's body). | 0.3 T (perpendicular to
patient's body). | |
| Fringe field | 5 G line at 1.4 m
maximum from the centre
of the magnet. | 5 G line at 2.5 m
maximum from the centre
of the magnet. | |
| Gantry opening | 620 mm x 240 mm (w x h) | 1000 x 380 mm(w x h) | |
| Magnetic
system weight | 1700 kg | 10000 kg | |
#### Radiofrequency System 1.
| Characteristic | ARTOSCAN S | AIRIS
K945155 | Comments |
|------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Solenoidal
receiver coils | Shoulder/Knee Coil
17.5x7.6x14.7 cm
Hip Coil
20 x 23 x 14 cm
(internal dimensions: w x d x h) | Large joint Coil (shoulder, knee)
18.4x23 cm wxh
Flexible body Coil (hip and other regions)
20x150 cm wxd | The technology of the solenoidal (or linear) coils is unchanged compared to the technology used for the ARTOSCAN M coils. Coils with different shapes |
{2}------------------------------------------------
| Characteristic | ARTOSCAN S | AIRIS
K945155 | Comments |
|----------------|------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | | | have been
developed to
adapt to the
geometrical
characteristics of
the gantry and to
the new limbs to
examine. |
| RF power | up to 600 W peak pulse | up to 5000 W peak pulse | |
#### Patient Positioning 1.
、
| Characteristic | ARTOSCAN S | AIRIS K945155 | Comments |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Patient comfort | The large magnet opening
and the device design, that
allows the patient to be
almost completely out of
the magnet, except the
examined portion, virtually
eliminate claustrophobia
and other related reactions
during the examination. | The large magnet opening
virtually eliminates the
anxiety and claustrophobia
often experienced by
patients in the narrow bore
of conventional MR imag-
ing systems. | |
| Patient
positioning | An adjustable couch is
used to position the
patient's limb inside the
gantry.
The couch is pushed into
the gantry manually. | An adjustable motorized
table is used to position the
patient inside the gantry. | The same
positioning
philosophy as
ARTOSCAN M,
suitable for the
new gantry
shape, has been
used for
ARTOSCAN S. |
:
{3}------------------------------------------------
#### Installation Area Conditions 1.
: 上一篇:
,
| Characteristic | ARTOSCAN S | AIRIS
K945155 | Comments |
|----------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------|
| Area necessary | 3.7 m x 3.7 m | 4 m x 5 m (gantry and
patient table)
4 m x 2.5 m (operator
console, MRI unit and
other components) | |
| RF shielding | Self contained RF
shielding (up to 30
dBμV/m).
External shielding (up to
100 dBμV/m). | The scan room must be RF
shielded to 60 dB. RF
noise inside the scan room
should meet 0.5-30 MHz,
0 dBμV/m or less. | |
#### 2. Magnetic System
| Characteristic | ARTOSCAN S | PRIMA 1TG
K970990 | Comments |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gradient
strength | 20 mT/m | whole-body set
21 mT/m | With higher
gradient strength
it is possible to
minimize at the
same time FOV
and slice
thickness, also
for sequences
with very short
TE, improving
the spatial
resolution. |
| | | | |
| Rise time | 0.5 msec from 0 to 20 mT
or from -20 to 0 mT | 0.5 msec to full amplitude
supplementary set
30 mT/m
0.41 msec to full amplitude | |
| | | | |
| Characteristic | ARTOSCAN S | ARTOSCAN M
K963262 | Comments |
| Data
acquisition
modes | Spin warp 2D/3D
Half Scan
Half Echo | Spin warp 2D/3D
Half Scan
Half Echo | Unchanged |
| Pulse sequences | Multiplanar Ortho-Scout
T1-weighted Spin Echo
(SET1)
T2-weighted Spin Echo
(SET2)
Multiple Spin-Echo
(MEDE)
Gradient Echo (GE)
Inversion Recovery (IR)
Short TI Inversion
Recovery (STIR)
Half Echo T1-weighted
Spin Echo (SET1HE)
Half Fourier T1-weighted
Spin Echo (SET1HF)
Turbo T2-weighted Spin-
Echo (TSE)
Turbo Multiple Spin-Echo
(TME)
Turbo Gradient Echo
(TGE)
3D Gradient Echo (GE3D)
Turbo 3D T1-weighted
Gradient Echo (T3D_T1)
Turbo 3D T2-weighted
Gradient Echo (T3D_T2)
Short TI Inversion
Recovery Gradient Echo
(GEFS)
Magnetization Transfer
(GEMT)
3D Magnetization Transfer
(GE3DMT) | Multiplanar Ortho-Scout
T1-weighted Spin Echo
(SET1)
T2-weighted Spin Echo
(SET2)
Multiple Spin-Echo
(MEDE)
Gradient Echo (GE)
Inversion Recovery (IR)
Short TI Inversion
Recovery (STIR)
Half Echo T1-weighted
Spin Echo (SET1HE)
Half Fourier T1-weighted
Spin Echo (SET1HF)
Turbo T2-weighted Spin-
Echo (TSE)
Turbo Multiple Spin-Echo
(TME)
Turbo Gradient Echo
(TGE)
3D Gradient Echo (GE3D)
Turbo 3D T1-weighted
Gradient Echo (T3D_T1)
Turbo 3D T2-weighted
Gradient Echo (T3D_T2)
Short TI Inversion
Recovery Gradient Echo
(GEFS)
Magnetization Transfer
(GEMT)
3D Magnetization Transfer
(GE3DMT) | Unchanged |
| Slice thickness | 2D FT: from 2 mm to 10
mm, step 0.5 mm
3D FT: from 0.6 mm to 10
mm, step 0.1 mm | 2D FT: from 2 mm to 10
mm, step 0.5 mm
3D FT: from 0.6 mm to 10
mm, step 0.1 mm | Unchanged |
| Interslice
spacing | Not necessary: contiguous
slicing is available | Not necessary: contiguous
slicing is available | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M K963262 | Comments |
| Slice orientation | Transverse
Sagittal
Coronal
Oblique
Multislice packages | Transverse
Sagittal
Coronal
Oblique
Multislice packages | Unchanged |
| Acquisition matrix | 2D FT: from 192x128 up to 256x256; phase encoding step 8
3D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | 2D FT: from 192x128 up to 256x256; phase encoding step 8
3D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | Unchanged |
| Spatial resolution | Up to 0.4 mm. | Up to 0.4 mm. | Unchanged |
| Multi-slice | 128 slices max (for each echo) | 128 slices max (for each echo) | Unchanged |
| Multi-echo | 2 echoes max | 2 echoes max | Unchanged |
| Scan parameters | TR
SET1: 50 ~ 5000 ms, step 10 ms
SET2: 200 ~ 5000 ms, step 10 ms
MEDE: 200 ~ 5000 ms, step 10 ms
GE: 60 ~ 5000 ms., step 10 ms
IR: 260 ~ 5000 ms, step 10 ms
STIR: 100 ~ 5000 ms, step 10 ms
SET1HE: 50 ~ 5000 ms, step 10 ms
SET1HF: 50 ~ 5000 ms, step 10 ms
TSE: 200 ~ 5000 ms, step 10 ms
TME: 200 ~ 5000 ms., step 10 ms
TGE: 30 ~ 5000 ms, step 5 ms
GE3D: 40 ~ 5000 ms, step 10 ms
T3D_T1: 25 ~ 5000 ms, step 5 ms | TR
SET1: 50 ~ 5000 ms, step 10 ms
SET2: 200 ~ 5000 ms, step 10 ms
MEDE: 200 ~ 5000 ms, step 10 ms
GE: 60 ~ 5000 ms., step 10 ms
IR: 260 ~ 5000 ms, step 10 ms
STIR: 100 ~ 5000 ms, step 10 ms
SET1HE: 50 ~ 5000 ms, step 10 ms
SET1HF: 50 ~ 5000 ms, step 10 ms
TSE: 200 ~ 5000 ms, step 10 ms
TME: 200 ~ 5000 ms., step 10 ms
TGE: 30 ~ 5000 ms, step 5 ms
GE3D: 40 ~ 5000 ms, step 10 ms
T3D_T1: 25 ~ 5000 ms, step 5 ms | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M
K963262 | Comments |
| | T3D_T2 : 35 ~ 5000 ms,
step 1 ms | T3D_T2 : 35 ~ 5000 ms,
step 1 ms | |
| | GEFS: 70 ~ 5000 ms., step
10 ms | GEFS: 70 ~ 5000 ms., step
10 ms | |
| | GEMT: 40 ~ 5000 ms,
step 5 ms | GEMT: 40 ~ 5000 ms,
step 5 ms | |
| | GE3DMT: 45 ~ 5000 ms,
step 5 ms | GE3DMT: 45 ~ 5000 ms,
step 5 ms | |
| TE | SET1: 16~34 ms, step 2 ms | SET1: 18 ~ 34 ms, step 2 ms | The sequences
are substantially
unchanged. For
some sequences
we used shorter
TE, to obtain a
more T1-
weighted
contrast. That is
possible thanks
the higher
gradient strength. |
| | SET2: 80~ 120 ms, step
10 ms | SET2: 80~ 120 ms, step
10 ms | |
| | MEDE: 1st echo 38 ms;
2nd echo 90 ms | MEDE: 1st echo 38 ms;
2nd echo 90 ms | |
| | GE: 12 ~ 24 ms, step 2 ms | GE: 12 ~ 24 ms, step 2 ms | |
| | IR: 16 ~ 34 ms, step 2 ms | IR: 18~34 ms, step 2 ms | |
| | STIR: 16 ~ 34 ms, step 2
ms | STIR: 18 ~ 34 ms, step 2
ms | |
| | SET1HE: 10 ~ 24 ms, step
2 ms | SET1HE: 12 ~ 24 ms, step
2 ms | |
| | SET1HF: 16 ~ 34 ms, step
2 ms | SET1HF: 18 ~ 34 ms, step
2 ms | |
| | TSE: 80 ~ 120 ms, step 10
ms | TSE: 80 ~ 120 ms, step 10
ms | |
| | TME: 1st echo 38 ms; 2nd
echo 90 ms | TME: 1st echo 38 ms; 2nd
echo 90 ms | |
| | TGE: 8 ~ 24 ms, step 1 ms | TGE: 8 ~ 24 ms, step 1 ms | |
| | GE3D: 8 ~ 24 ms, step 1
ms | GE3D: 14~24 ms, step 2
ms | |
| | T3D_T1: 8~24 ms, step
1 ms | T3D_T1: 8~24 ms, step
1 ms | |
| | T3D_T2 : fixed at 16 ms | T3D_T2 : fixed at 16 ms | |
| | GEFS: 8 ~ 24 ms, step 1
ms | GEFS: 12 ~ 24 ms, step 2
ms | |
| | GEMT: 8 ~ 24 ms, step 1
ms | GEMT: 8 ~ 24 ms, step 1
ms | |
| | GE3D MT: 8 ~ 24 ms, step
1 ms | GE3D MT: 8 ~ 24 ms, step
1 ms | Unchanged |
| TI | IR: 200 ~ 800 ms, step 10
ms | IR: 200 ~ 800 ms, step 10
ms | |
| | STIR: 50~200 ms, step 5
ms | STIR: 50~200 ms, step 5
ms | |
| Characteristic | ARTOSCAN S | ARTOSCAN M
K963262 | Comments |
| | GEFS : 20 ~ 200 ms, step
5 ms | GEFS : 20 ~ 200 ms, step
5 ms…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/LHN/K981358](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/LHN/K981358)
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