(47 days)
Not Found
No
The summary describes a standard MRI system and its components, focusing on its mechanical features and imaging capabilities. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is an MR imaging system intended to produce images for diagnostic purposes, not for treating conditions.
Yes
The device is described as producing images that, when interpreted by a medical expert, "can provide diagnostically useful information." This indicates its role in aiding in the diagnosis of medical conditions.
No
The device description explicitly lists multiple hardware components, including a magnetic unit, electronics box, operating console (PC unit, monitor, operating table), receiving coils, and a modular shielding box. 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.
- G-scan's Function: The G-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 clearly states it's for "imaging portions of the limbs, joints and spinal column" to provide "diagnostically useful information" when interpreted by a medical expert. This is consistent with an imaging device, not an IVD.
Therefore, the G-scan is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
G-scan is an open MRI system designed specifically to image limbs, joints and the spinal column.
The system is equipped with a hydraulic mechanism that will rotate both the magnet and the patient table from horizontal to vertical position, as shown in the following figures.
The patient may be scanned while lying down in a horizontal position and later he can be scanned vertically, in the weight bearing state, limited to the ankle, knee, hip and shoulder joint, and the spine.
The system is composed of these main parts:
-
- Magnetic unit.
-
- Electronics box.
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Receiving coils.
-
- Modular shielding box with filter panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) System
Anatomical Site
limbs, joints, spinal column (upper limb (hand, wrist, forearm, elbow, arm, shoulder), lower limb (foot, ankle, calf, knee, thigh), spinal column (cervical, thoracic, 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): 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.
K032121, K001334, K940894, K994345, K011311
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
§ 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 ( i->c .Hi Esaote. S.p.A.
OC1 4 - 2004
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specificd in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Carri Graham, Official Correspondent
8000 Castleway Drive
Indianapolis, IN 46250
Phone:
Facsimile: | (317) 849-1916
(317) 577-9070 |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Contact Person: | Carri Graham |
| Date: | August 13, 2004 |
| 807.92(a)(2) | |
| Trade Name: | G-scan |
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification Number: | 90LNH |
807.92(a)(3)
Predicate Device(s)
| Tradename | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| E-scan XQ | System, nuclear | ||||
| magnetic resonance | |||||
| imaging | II | LNH | ESAOTE S.P.A. | K032121 | |
| AIRIS II | System, nuclear | ||||
| magnetic resonance | |||||
| imaging | II | LNH | HITACHI MEDICAL | ||
| SYSTEMS | K001334 | ||||
| MAGNA SL | System, nuclear | ||||
| magnetic resonance | |||||
| imaging | II | LNH | MAGNA-LAB | K940894 | |
| Magna 5000 | |||||
| Phased Array | |||||
| CTL Spine | |||||
| Coil | Coil, Magnetic | ||||
| Resonance, Specialty | II | MOS | USA INSTRUMENTS | K994345 | |
| UROLOGIC | Table, radiographic, | ||||
| tilting | II | IXR | PCK ELECTRONIC | ||
| INDUSTRY | K011311 |
1
"01.92(a)(4)
Device Description
G-scan is an open MRI system designed specifically to image limbs, joints and the spinal column.
The system is equipped with a hydraulic mechanism that will rotate both the magnet and the patient table from horizontal to vertical position, as shown in the following figures.
The patient may be scanned while lying down in a horizontal position and later he can be scanned vertically, in the weight bearing state, limited to the ankle, knee, hip and shoulder joint, and the spine.
The system is composed of these main parts:
-
- Magnetic unit.
-
- Electronics box.
-
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
-
- Receiving coils.
-
- Modular shielding box with filter panel.
807.92(a)(5)
Intended Use(s)
7-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection 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 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), spinspin 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.
2
307.92(a)(6)
Technological Characteristics
1. Imaging System
| Characteristic | G-scan | AIRIS II | Comments |
|---|---|---|---|
| K001334 | |||
| Clinical use | Portions of the upper limb, | ||
| including hand, wrist, | |||
| forearm, elbow, arm and | |||
| shoulder. | |||
| Portions of the lower limb, | |||
| including foot, ankle, calf, | |||
| knee, thigh and hip. | |||
| Portions of the spinal | |||
| column, including the | |||
| cervical, thoracic and | |||
| lumbo-sacral sections. | Whole body, central | ||
| nervous system and | |||
| orthopaedic regions. | The spinal | ||
| column has been | |||
| introduced for | |||
| examination. | |||
| Pulse sequences | Turbo Spin Echo 7 | Fast Spin Echo | All the other |
| pulse sequences | |||
| are the same of | |||
| E-scan XQ, | |||
| K032121. | |||
| The Turbo Spin | |||
| Echo 7 is | |||
| described in the | |||
| "Device | |||
| Description" | |||
| section. | |||
| Field of view | From 100 up to 350 mm, | ||
| step 10 mm (250 mm are | |||
| displayed). | From 50 up to 350 mm, | ||
| step 1 mm | A larger FOV is | ||
| available to | |||
| better cover the | |||
| anatomical parts | |||
| to be imaged. |
2. Magnetic System
| Characteristic | G-scan | AIRIS II
K001334 | Comments |
|---------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|----------|
| Static field
intensity | 0.24 T. | 0.3 T | |
| Fringe field | 0.5 mT line at 1.8 m
maximum from the centre
of the magnet. | 0.5 mT line at 2.5 m
maximum from the centre
of the magnet. | |
| Gantry opening | 33 cm high | 38 cm high | |
3
510(k) Summary (i-scan Esaote. S.p.A.
| Characteristic | G-scan | MAGNA SL
K940894 | Comments |
|-----------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Field direction | Vertical or horizontal,
according to system
orientation, between the
two "C" faces | Vertical or horizontal, according
to system orientation, between
the two "C" faces | The rotation of
the magnet,
together with the
patient table,
allows the
weight bearing
examination.
The rotation
system is
described in the
"Device
Description"
section. |
| Characteristic | G-scan | E-scan XQ
K032121 | Comments |
| Homogeneity |