(28 days)
No
The summary explicitly states that the modifications "do not affect the intended use or alter the fundamental scientific technology of the device" and lists only hardware and software upgrades related to system performance and patient positioning. There is no mention of AI or ML in the description of the device or its capabilities.
No
The device is an MR system intended for imaging and producing diagnostic information. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This explicitly indicates the device's role in providing information for diagnosis.
No
The device description explicitly lists multiple hardware components that have been modified or introduced, such as a new patient table, footboard, seat, control panel, hydraulic circuit, and electronics. While a new software release is mentioned, it is listed as one of several modifications to a physical MR system.
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 Brio Function: The G-scan Brio is a Magnetic Resonance (MR) system. It produces images of internal body structures by using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use is to produce images for diagnostic information when interpreted by a medical expert. This is a characteristic of imaging devices, not IVDs.
Therefore, the G-scan Brio falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
G-scan Brio 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, imaging the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
G-scan Brio 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)
LNH, LLZ, MOS
Device Description
The changes performed on the modified G-scan device (G-scan Brio), with respect to the cleared version - G-scan K111803 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
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- A new patient table that can be moved manually in the inner/outer direction of the gantry.
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- A new footboard and seat for vertical examinations.
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- A patient table extension.
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- A back support.
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- A new step for patient positioning.
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- A new control panel on the front of the magnet.
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- Upgrading of the hydraulic circuit.
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- Upgrading of the electronics.
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- 4-channels Lumbar spine coils N.17 and 18 introduction, cleared via K110802.
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- A new software release.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs, joints, spinal column, portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, the temporomandibular joint, the cervical spine and the lumbar spine 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)
Non-clinical testing of the G-scan Brio system demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
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.
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.
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 | K122006 | ||
|---|---|---|---|
| G-scan Brio | |||
| Esaote S.p.A. | |||
| 510(k) Summary | |||
| AUG 6 2012 |
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
Donatella Ragghianti Esaote, S.p.A. Via Siffredi 58 Genova 16153 Italy
Contact Person: Allison Scott, RAC P: 317.569.9500 x106 F: 317.569.9520 ascott@ansongroup.com
July 6, 2012 Date:
Trade Name: G-scan Brio
Common Name: System, Nuclear Magnetic Resonance Imaging
Classification Name(s): Magnetic Resonance Diagnostic Device
Classification Number: аогин
Predicate Device(s)
| Trade Name | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| G-scan | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | ESAOTE S.P.A. | K111803 |
1
510(k) Summary G-scan Brio Esaote S.p.A. - - - -