Who is the manufacturer of S-SCAN MRI SYSTEM?

Esaote, S.p.A. filed the 510(k) submission for S-SCAN MRI SYSTEM (K063207).

What is the FDA product code for S-SCAN MRI SYSTEM?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for S-SCAN MRI SYSTEM?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like S-SCAN MRI SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

S-SCAN MRI SYSTEM

Q: What are the predicate devices for S-SCAN MRI SYSTEM?

Esaote G-scan (K042236); Esaote E-scan Opera (K060956); Siemens Magnetom C! (K043030); USA Instruments Magna 5000 Phased Array CTL Spine Coil (K994345).

K063207 · Esaote, S.p.A. · LNH · Nov 9, 2006 · Radiology

Device Facts

Record ID	K063207
Device Name	S-SCAN MRI SYSTEM
Applicant	Esaote, S.p.A.
Product Code	LNH · Radiology
Decision Date	Nov 9, 2006
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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 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.

Device Story

S-scan is a magnetic resonance imaging (MRI) system for musculoskeletal diagnostics. It acquires proton density signals from limbs and spine; transforms signals into cross-sectional images via pulse sequences and reconstruction algorithms. Operated by trained medical professionals in clinical settings. System includes patient table, magnetic unit with display panel, and operating console. Display panel provides real-time sequence preview for patient positioning. Output images are interpreted by radiologists/clinicians to identify anatomical structures and pathologies. Benefits include non-invasive diagnostic visualization of joints and spinal column. Modifications from predicate G-scan include manual patient table, upgraded electronics, new receiving coils (DPA Lumbar, Cervical), modified pulse sequences, and new software release.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, technical specifications, and comparison of imaging performance to predicate devices.

Technological Characteristics

Magnetic resonance diagnostic device. Components: patient table (200kg capacity), magnetic unit, operating console, electronics box. Pulse sequences: SE, TSE, IR, STIR, Gradient Echo, Real Time. Multi-channel reconstruction: SoS technique. Connectivity: PC-based console. Coils: DPA Lumbar, Cervical, Shoulder, Knee, Hand, Foot/Ankle, Flexible.

Indications for Use

Indicated for MR imaging of upper limbs (hand, wrist, forearm, elbow, arm, shoulder), lower limbs (foot, ankle, calf, knee, thigh, hip), and spinal column (cervical, lumbo-sacral sections). For use by trained medical experts.

Regulatory Classification

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 G-scan (K042236)
Esaote E-scan Opera (K060956)
Siemens Magnetom C! (K043030)
USA Instruments Magna 5000 Phased Array CTL Spine Coil (K994345)

Related Devices

K131996 — S-SCAN · Esaote, S.p.A. · Dec 13, 2013
K151668 — S-scan · Esaote, S.p.A. · Sep 8, 2015
K121650 — S-SCAN · Esaote, S.p.A. · Jul 9, 2012
K110238 — G-SCAN · Esaote, S.p.A. · Feb 17, 2011
K080968 — S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA · Esaote, S.p.A. · Apr 29, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ K063207 # 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: - 1. A new patient table that can be moved only manually. Neither the patient table nor the magnet can rotate from horizontal to vertical position. - 2. A modified support to hold up the magnet and the gantry. - 3. A new display panel on the front of the magnet. - 4. Some different external covers due to the new patient table and support. - 5. Upgrading of the electronics. - 6. Two new receiving coils: DPA Lumbar spine coil N.10 and Cervical spine coil N.9 - 7. Modified pulse sequences - 8. A modified version of the magnet poles and of the gradient coils. - 9. A new software release. # S-scan The system is composed of these main parts: - 1. Patient positioning table. - 2. Magnetic unit with the display panel. - 3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table. - 4. 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.…