Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard MRI technology and image processing techniques (filtering) without mentioning AI or ML.

Therapeutic

No.
The device's intended use is explicitly stated as "diagnostic nuclear magnetic resonance imaging" for producing images that provide "diagnostically useful information," not for treating conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic nuclear magnetic resonance imaging" and that the images produced "can provide diagnostically useful information." The "Device Description" also refers to it as a "magnetic resonance diagnostic device."

SaMD (Software as a Medical Device)

No

The device description clearly outlines significant hardware components including a permanent magnet system, coils, a central processing unit, and other physical components necessary for magnetic resonance imaging. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Artoscan S is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The Artoscan S is a magnetic resonance imaging device that directly images the internal structure of the human body (limbs and joints) without requiring the collection and analysis of biological samples.
The intended use describes imaging the body directly. The description clearly states it's for "diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand."
The device description details hardware for imaging the body. The components listed (magnet system, coils, processors, display) are all consistent with an in-vivo imaging system, not a system for analyzing biological specimens.

Therefore, the Artoscan S falls under the category of in-vivo diagnostic imaging devices, not in-vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Product codes (comma separated list FDA assigned to the subject device)

90LNH

Device Description

Not Found

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical expert

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.

K963262, K945155, K970990

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

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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

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: 1634 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: 1834 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: 1424 ms, step 2
ms | |
| | T3D_T1: 824 ms, step
1 ms | T3D_T1: 824 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: 50200 ms, step 5
ms | STIR: 50200 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 | |
| | FA | FA | Unchanged |
| | GE: fixed at 90º | GE: fixed at 90º | |
| | TGE: 10º ~ 90º, step 5º | TGE: 10º ~ 90º, step 5º | |
| | GE3D: 10º ~ 90º, step 5º | GE3D: 10º ~ 90º, step 5º | |
| | T3D_T1: 10º ~ 90º, step
5º | T3D_T1: 10º ~ 90º, step
5º | |
| | T3D_T2 : fixed at 90º | T3D_T2 : fixed at 90º | |
| | GEFS : fixed at 90º | GEFS : fixed at 90º | |
| | GEMT: 10º~ 90º, step 5º | GEMT: 10º ~ 90º, step 5º | |
| | GE3DMT: 10º ~ 90º, step
5º | GE3DMT: 10º ~ 90º, step
5º | |

4

3. Imaging System

の人気の人気の人気の人気の人気の人気の

»

5

:

6

.

:

7

3. Radiofrequency System

Characteristic	ARTOSCAN S	ARTOSCAN M	Comments
DPA receiver
coils	DPA Knee Coil
14.2x17.8x15.8 cm
DPA Ankle Coil
8.7x21.4x14.6 cm
DPA Hand/Wrist Coil
7.2x18.6x11.9 cm
(internal dimensions: w x d
x h)	DPA Knee Coil
12.5x19.3x13.7 cm
DPA Ankle Coil
8.7x21.4x14.6 cm
DPA Hand/Wrist Coil
7.2x18.6x11.9 cm
(internal dimensions: w x d
x h)	The technology
of the DPA (or
quadrature) coils
is unchanged
compared to the
technology used
for the
ARTOSCAN M
coils. A more
comfortable knee
coil has been
developed.

3. Image Processing and Display System

Characteristic	ARTOSCAN S	ARTOSCAN M	Comments
Central
processing unit	CPU: Pentium 200 MHz
Main memory: 32 MB;
256 KB cache memory	CPU: Pentium 200 MHz
Main memory: 32 MB;
256 KB cache memory	Unchanged
Control
processor	16.7 MIPS, 0.5 MB
memory	16.7 MIPS, 0.5 MB
memory	Unchanged
Acquisition and
reconstruction
processor	33 MFlops, 65 MB
memory	33 MFlops, 65 MB
memory	Unchanged
Hard disk unit	3"½; 2.6 GB	3"½; 2.6 GB	Unchanged
Characteristic	ARTOSCAN S	ARTOSCAN M	Comments

Rewritable
optical disk unit	3"½, R/W, 640 MB, 1 side	3"½, R/W, 640 MB, 1 side	Unchanged
Image
reconstruction
time	2D
1 sec/img in Format1 with
visualization
0.8 sec/img in Format4
with visualization
3D
≈ 35 sec for reconstructing
a 256x256x128 data cube,
to calculate the three Scout
images and to save the
image cube (256x256x128,
8 bit/pixel)	2D
1 sec/img in Format1 with
visualization
0.8 sec/img in Format4
with visualization
3D
≈ 35 sec for reconstructing
a 256x256x128 data cube,
to calculate the three Scout
images and to save the
image cube (256x256x128,
8 bit/pixel)	Unchanged
Display matrix	Format1: 510x478;
Format4: 254x238;	Format1: 510x478;
Format4: 254x238;	Unchanged
Grey scale	4096 (0+4095) Grey
levels in 2D
256 Grey levels in 3D	4096 (0+4095) Grey
levels in 2D
256 Grey levels in 3D	Unchanged
Display
monitor	17" Colour 640x480 pixel,
60 Hz non-interleaved,
high contrast	17" Colour 640x480 pixel,
60 Hz non-interleaved,
high contrast	Unchanged
The DHHS
Accession
Number is:
9531534-07.
Image filtering	Automatic image filtering
in visualization by an
adaptive filter, depending
on the image acquisition
parameters characterizing
the image to be filtered.
Non-automatic image
filtering by three types of
adaptive filters and two
types of non-adaptive fil-
ters.	Automatic image filtering
in visualization by an
adaptive filter, depending
on the image acquisition
parameters characterizing
the image to be filtered.
Non-automatic image
filtering by three types of
adaptive filters and two
types of non-adaptive fil-
ters.	Unchanged
Networking
functions	Printing of images that
have been pre-formatted in
DICOM3 protocol form.
Sending images in
DICOM3 protocol form
using TCP/IP.
Sending images to other
systems of the	Printing of images that
have been pre-formatted in
DICOM3 protocol form.
Sending images in
DICOM3 protocol form
using TCP/IP.
Sending images to other
systems of the	Unchanged
Characteristic	ARTOSCAN S	ARTOSCAN M	Comments
	ARTOSCAN-Dedicated
MRI family using TCP/IP
or PPP (Modem).	ARTOSCAN-Dedicated
MRI family using TCP/IP
or PPP (Modem).

8

9

Patient positioning 3.

. . . .

Characteristic	ARTOSCAN S	ARTOSCAN M	Comments
Limb fastening	All coils are especially
designed to keep the
examined limb in the
proper position.	All coils are especially
designed to keep the
examined limb in the
proper position.	Unchanged

Installation Area Conditions 3.

Characteristic	ARTOSCAN S	ARTOSCAN M	Comments
Type of
installation	Fixed area ("permanently
installed" according to EN
60601-1)	Fixed area ("permanently
installed" according to EN
60601-1)
Mobile	Differently from
ARTOSCAN M,
ARTOSCAN S
has not a mobile
configuration.

Note: Any deviations from original ARTOSCAN M specifications are substantiated within Quality System documentation at Esaote S.p.A..

10

Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle, represented by three curved lines that suggest feathers or wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 1998

Colleen Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, IN 46250 Re:

K981358 Artoscan S ( MRI System ) Dated: April 13, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LHN

Dear Ms. Hittle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Apporal), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

Indications For Use

510(k) Number (if known):

ﮨﮯ ۔ ﮨ

K 98/358

Device Name:

Artoscan S

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use __

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981358

રેસ