(17 days)
Not Found
No
The document describes a standard MR imaging system and does not mention any AI or ML components or functionalities.
No
The device is an imaging system (MR system) intended for diagnosis, as it produces images for interpretation by a medical expert. It does not perform any therapeutic function.
Yes
Explanation: The device produces images (MR scans) that, "when interpreted by a medical expert trained in the use of MR equipment, ... can provide diagnostically useful information." This explicitly states its role in providing diagnostic information.
No
The device description explicitly lists multiple hardware components (patient positioning table, magnetic unit, operating console with PC, electronics box) that are integral to the device's function as an MR system. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The S-scan is a Magnetic Resonance (MR) system. It produces images of internal body structures (limbs, joints, spinal column) by using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide diagnostically useful information through imaging, interpreted by a medical expert. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro testing.
Therefore, the S-scan falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-scan 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.
Product codes
LNH
Device Description
The changes performed on the modified G-scan device (S-scan), with respect to the cleared version - G-scan K042236 -, 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:
-
- A new patient table that can be moved only manually. Neither the patient table nor the magnet can rotate from horizontal to vertical position.
-
- A modified support to hold up the magnet and the gantry.
-
- A new display panel on the front of the magnet.
-
- Some different external covers due to the new patient table and support.
-
- Upgrading of the electronics.
-
- Two new receiving coils: DPA Lumbar spine coil N.10 and Cervical spine coil N.9
-
- Modified pulse sequences
-
- A modified version of the magnet poles and of the gradient coils.
-
- A new software release.
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit with the display panel.
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Electronics box with filter panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs, joints, spinal column (upper limb: hand, wrist, forearm, elbow, arm and shoulder; lower limb: foot, ankle, calf, knee, thigh and hip; spinal column: cervical and lumbo-sacral sections)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in the use of MR equipment
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)
K042236, K060956, K043030, K994345
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
NOV - 9 2006
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 (317) 569-9500 X 103 Phone: (317) 569-9520 Facsimile:
Contact Person: Carri Graham
October 19, 2006 Date:
807.92(a)(2)
| Trade Name: | S-scan |
|---|---|
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic resonance diagnostic device |
| Classification Number: | 90LNH |
| 807.92(a)(3) | Predicate Device(s) | |
|---|---|---|
| Esaote | G-scan | K042236 |
| Esaote | E-scan Opera | K060956- |
| Siemens | Magnetom C! | K043030 |
| USA Instruments | Magna 5000 | |
| Phased Array | ||
| CTL Spine Coil | K994345 |
1
807.92(a)(4)
Device Description
Summary of G-scan modifications
The changes performed on the modified G-scan device (S-scan), with respect to the cleared version - G-scan K042236 -, 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:
-
- A new patient table that can be moved only manually. Neither the patient table nor the magnet can rotate from horizontal to vertical position.
-
- A modified support to hold up the magnet and the gantry.
-
- A new display panel on the front of the magnet.
-
- Some different external covers due to the new patient table and support.
-
- Upgrading of the electronics.
-
- Two new receiving coils: DPA Lumbar spine coil N.10 and Cervical spine coil N.9
-
- Modified pulse sequences
-
- A modified version of the magnet poles and of the gradient coils.
-
- A new software release.
S-scan
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit with the display panel.
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Electronics box with filter panel.
2
807.92(a)(5)
Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR paranteters, including spin-lattice 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.
3
807.92(a)(6)
Technological Characteristics
| Characteristic | S-scan | G-scan K042236 | Comments |
|---|---|---|---|
| Pulse Sequences | Orthogonal Multi-planar Scout | Orthogonal Multi-planar Scout | The S-scan pulse |
| sequences are a | |||
| modified version | |||
| of the G-scan | |||
| pulse sequences | |||
| as described in | |||
| the Device | |||
| Modification | |||
| Description and | |||
| Software | |||
| Description | |||
| sections. | |||
| Spin Echo T1 | Spin Echo T1 | ||
| Spin Echo T2 | Spin Echo T2 | ||
| Spin Echo Proton Density T2 | Spin Echo Proton Density T2 | ||
| Inversion Recovery | Inversion Recovery | ||
| Short TI Inversion Recovery | Short TI Inversion Recovery | ||
| Spin Echo T1 Half Echo | Spin Echo T1 Half Echo | ||
| Spin Echo T1 Half Fourier | Spin Echo T1 Half Fourier | ||
| Turbo Spin Echo T2 weighted | |||
| (TSE, TSE S, TSE SA, TSE SP) | Turbo Spin Echo T2 weighted | ||
| (TSE) | |||
| Turbo Multi Echo | Turbo Multi Echo | ||
| Gradient Echo | Gradient Echo | ||
| Short Time Inversion Recovery | Short Time Inversion Recovery | ||
| Gradient Echo (Gradient Echo | |||
| STIR) | Gradient Echo (Gradient Echo | ||
| STIR) | |||
| Gradient Echo 3D (Turbo 3D T1) | Gradient Echo 3D (Turbo 3D T1) | ||
| Speed — Spin Echo T2 (SSE-SET2, | |||
| SSE-SET2 S, SSE-SET2 SA, SSE- | |||
| SET2 SP) | |||
| Speed — Spin Echo T2 (SSE-SET2 |
1-2-3) | | |
| | Real Time | Real Time | |
| Receiving coils | 1 Shoulder coil | 1 Shoulder coil | The linear coil
of the DPA
Lumbar Spine
coil n.10 is equal
to the Thoracic—
Lumbar Spine
coil n.8. The
whole coil is
equivalent to the
Magna 5000
Phased Array
CTL Spine Coil
K994345,
available on
other
commercial
scanners.
See Device
Modification
Description
section |
| | 2 Knee coil | 2 Knee coil | |
| | 3 Hand coil | 3 Hand coil | |
| | 4 Foot/Ankle coil | 4 Foot/Ankle coil | |
| | 6 Flexible coil | 6 Flexible coil | |
| | 7 Shoulder coil | 7 Shoulder coil | |
| | 9 Cervical Spine coil | 8 Thoracic — Lumbar Spine coil | |
| | 10 Lumbar Spine coil | 9 Cervical Spine coil | |
| Characteristic | S-scan | G-scan K042236 | Comments |
| Multi-channel
reconstruction | SoS technique | | This technique is
already in place
on many multi-
channel MRI
systems as, for
instance,
MAGNETOM
C! (K043030).
See Device
Modification
Description
section. |
| Indications for
Use | S-scan is a Magnetic Resonance
(MR) system that produces
transversal, sagittal and coronal
and oblique cross-section images
of the limbs, joints and spinal
column. It is intended for imaging
portions of the upper limb,
including the hand, wrist, forearm,
elbow, arm and shoulder, imaging
portions of the lower limb,
including the foot, ankle, calf,
knee, thigh and hip and imaging
portions of the spinal column,
including the cervical and lumbo-
sacral sections.
S-scan 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. | G-scan is a Magnetic Resonance
(MR) system that produces
transversal, sagittal and coronal
and oblique cross-section images
of the limbs, joints and spinal
column. It is intended for imaging
portions of the upper limb,
including the hand, wrist, forearm,
elbow, arm and shoulder, imaging
portions of the lower limb,
including the foot, ankle, calf,
knee, thigh and hip and imaging
portions of the spinal column,
including the cervical, thoracic and
lumbo-sacral sections.
G-scan 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. | |
| Characteristic | S-scan | E-scan Opera K060956 | Comments |
| Patient table | Maximum load-bearing capacity =
200 kg (approx. 440 lb)
fixed height (740 cm)
it can be rotated and removed from
magnet cavity to facilitate patient
positioning and
to enable various positions in
relation to the region examined
washable covering material
manual positioning
integrated in overall design of
equipment. | Maximum load-bearing capacity =
200 kg (approx. 440 Ib)
fixed height (710 cm)
removable from magnet cavity to
facilitate patient positioning
one section of the bed can be
rotated to enable various positions
in relation to the region examined
washable covering material
manual positioning
integrated in overall design of
equipment. | See Device
Modification
Description
section |
| Magnetic unit
display panel | The function of the Display Panel
is displaying real time sequences
for patient positioning.
Present commands:
Preview: begins the real time
sequence and displays the acquired
image on the LCD panel in the
selected orientation (sagittal, axial,
coronal).
Abort: stops the running sequence.
integrated in overall design of
equipment. | The function of the Display Panel
is displaying real time sequences
for patient positioning.
Present commands:
Preview: begins the real time
sequence and displays the acquired
image on the LCD panel in the
selected orientation (sagittal, axial,
coronal).
Abort: stops the running sequence.
integrated in overall design of
equipment. | See Device
Modification
Description
section |
| Electronics box | ALDIM unit: supplies the Display
Panel. | ALDIM unit: supplies the Display
Panel. | See Device
Modification
Description
section. |
| Image
visualization | RF saturation pulses to suppress
flow and motion artifacts.
The Repetition Time (TR) of each
sequence can be set using fixed
step so that 50 or 60 Hz artifacts
can be avoided.
Algorithm to avoid wrap around
artifacts through oversampling.
Flow compensation through the
Gradient moment nulling
technique. | RF saturation pulses to suppress
flow and motion artifacts.
The Repetition Time (TR) of each
sequence can be set using fixed
step so that 50 or 60 Hz artifacts
can be avoided. | The
oversampling
and the gradient
moment nulling
(GMR -
Gradient Motion
Rephasing) are
available on
other
commercial
scanners as, for
instance,
MAGNETOM
C! (K043030).
See Software
Description
section |
4
5
6
Image /page/6/Picture/1 description: The image shows a logo with a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. To the left of the bird symbol, there is text arranged in a circular fashion, which appears to be the name of an organization or department. The text is oriented to follow the curve of the circle, and the overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Esaote, S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032
NOV - 9 2006
Re: K063207
Trade/Device Name: S-scan MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 19, 2006 Received: October 23, 2006
Dear Ms. Graham:
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 (Premarket Approval), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/6/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a cursive font. There are three small dots arranged horizontally at the bottom of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Protecting and Promoting Public Health
7
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ KOGS20 |
Device Name: S-scan MRI System
Indications for Use:
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-scan 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Nancy C Broadon
(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __