(87 days)
P830076, K951681
No
The summary describes a standard MRI system and its physical components, focusing on image acquisition and basic processing. There is no mention of AI, ML, or any advanced image analysis or interpretation features that would typically indicate the use of such technologies.
No
The device is described as an imaging system intended for diagnostic purposes (producing images to yield diagnostically useful information), not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced by the system, "when interpreted by a trained physician, can yield diagnostically useful information." This indicates its role in providing information for diagnosis.
No
The device description explicitly details the physical components of an MRI system, including the magnet, coils, power source, and chiller system. While it mentions software for imaging sequences and data processing, the core of the device is hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "producing images of multiple planes in the head and body" and that these images "display the internal structure of the head and body, and when interpreted by a trained physician, can yield diagnostically useful information." This describes an imaging device used for in-vivo (within the living body) diagnosis, not in-vitro (outside the living body) testing of biological samples.
- Device Description: The description details the components and operation of a Magnetic Resonance Imaging (MRI) system, which is a type of medical imaging equipment used on patients.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the FONAR 360° Magnetic Resonance Imaging System is a medical imaging device for in-vivo diagnostic use, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FONAR 360° Magnetic Resonance Imaging System is indicated for use in producing images of multiple planes in the head and body. These images correspond to the distribution of hydrogen nuclei exhibiting nuclear magnetic resonance (NMR) and depend for their contrast upon NMR parameters [hydrogen nuclei concentration and flow velocity, T1 (spinlattice relaxation time) and T2 (spin-spin relaxation time)]. As a result of the acquisition and processing of the NMR data, these images display the internal structure of the head and body, and when interpreted by a trained physician, can yield diagnostically useful information.
WARNING: This device is limited by U.S. Federal law to investigational use for indications not in the indications statement.
Under the requirements of the law, the non-indicated applications can be used only under an Institutional Review Board approved protocol for a non-significant risk device or an Investigational Device Exemption application approved by the FDA for a significant risk device. The procedures to be followed, under the sponsorship of FONAR Corporation, are determined by the current guidelines established by the FDA, which should provide the IRB with sufficient guidance to determine the level of risk for a MRI device.
WARNING: U.S. Federal law restricts the sale, distribution and use of this device by or on the order of a physician.
Product codes
LNH
Device Description
The FONAR 360° magnet follows the same basic design, operating and physical principles, and construction methods and materials of the predicate magnets. The field strength of this magnet is 6000 gauss (0.6T). This magnet configuration is essentially a combination of basic structural elements of Fonar's previously approved magnets. The two pole assemblies of the vertical-field iron-core electromagnet are separated and supported by steel supports that form the "walls", "ceiling" and "floor" of the room-sized magnet. This provides an unimpeded 360° access to the magnet's imaging gap. The electromagnet coil elements are windings of multiple turns of epoxy-insulated copper installed around the poles of the magnet frame, connected to a regulated power source, and chilled via the closed loop chiller system.
During operation, the poles of the magnet establish a vertical magnet field with a limited fringe field. The magnetic field is created by passing a regulated DC current through the coil windings surrounding the magnet poles. The field strength is proportional to the amount of current in the coils. In this magnet the current supplied will result in a magnetic field of 6000 gauss, +/- 5% (0.6T +/- 5%), operating at frequencies between 24.27 and 26.92 MHz. This magnet functions with all imaging sequences available in the current software releases. All other non-magnet related equipment and procedures used are as previously reviewed by the FDA in PMA 830076, its supplements, and the 510(k) submissions K910839 and K951681.
Mentions image processing
As a result of the acquisition and processing of the NMR data, these images display the internal structure of the head and body, and when interpreted by a trained physician, can yield diagnostically useful information.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head and body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
A series of non-clinical tests and a period of human imaging were performed to demonstrate the safety and effectiveness of the FONAR 360° magnet, and to establish substantial equivalence to the predicate magnets. All testing was conducted in accordance with current FDA guidance documents and applicable device regulations, such as the NEMA standards. Results from all testing demonstrate substantial equivalence to the predicate devices.
Non-Clinical Testing:
The following specific parameters have been identified by the FDA as being pertinent to patient safety and highlighted for inclusion in 510(k) submissions. The majority of these concerns are specifically tested by comparison to the NEMA standards. The results of those NEMA tests not listed below will be included in this summary in tabular form. The new magnet does not significantly affect any of these parameters. The FONAR 360° magnet values for each of the concerns are indicated below.
- a. Static Field Strength: 0.6T +/- 5%
- b. Peak A-Weighted acoustic noise: 88.2 +/- 0.8 dBA
- c. Description of operational modes of the system: Normal mode only
- d. Maximum SAR for transmitter:
§ 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
MAR 1 6 2000
Fonar Corporation 110 Marcus Drive Melville, New York 11747-4292
December 9, 1999
510(k) Summary
Submitter Information:
| Company | FONAR Corporation
Registration Number 2432211
110 Marcus Drive, Melville, New York 11747-4292 | | |
|----------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------|--|
| Contact: | Luciano Bonanni
Phone: (631) 694-2929
E-mail: lbonanni@fonar.com | Executive Vice President
Fax: (631) 249-3734 | |
Device Designation:
| Device Name: | FONAR 360° Magnetic Resonance Imaging Scanner |
|---|---|
| Common Name: | Magnetic Resonance Imaging Scanner (MRI Scanner) |
| Classification: | System, Nuclear Magnetic Resonance Imaging (NMR/MRI) |
| Product Code: | LNH (formerly 90JAM) Class: 2 Tier: 2 |
| C.F.R. Section | 892.1000 |
| Classification Panel: | Radiology |
Applicable Performance Standards
On April 9, 1999. Intertek Services Corporation certified the Fonar Quality Management System to the standards EN ISO9001, BS EN9001 and ANSI/ASQC Q9001-1994. On May 25, 1999, the Fonar Quad 12000 was awarded the CE certificate and the quality system was certified to the additional standard of EN46001:1997. Our manufacturing systems were tested against the standards IEC 60601-1 (1988), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-04), IEC 60601-2-32 (1994-03) and IEC 60601-2-33 (1995-07). As part of the design/testing process for new products, Fonar utilizes the NEMA standards MS-1 through MS-8 for measuring performance and safety parameters (the standard MS-6 is not applicable to this submission). Images exported from the system utilize the DICOM standard.
Predicate Devices:
The magnet used in the FONAR 360° system is substantially equivalent to the magnet in use with the Fonar B3000 (P830076) and Quad 12000 (K951681) magnetic resonance imaging scanners. These magnets were selected as the predicate devices because of their similarities in intended use, magnetic field orientation, construction methods, materials and operating characteristics. They remain substantially equivalent to their previously approved forms.
1
Description of Device
The FONAR 360° magnet follows the same basic design, operating and physical principles, and construction methods and materials of the predicate magnets. The field strength of this magnet is 6000 gauss (0.6T). This magnet configuration is essentially a combination of basic structural elements of Fonar's previously approved magnets. The two pole assemblies of the vertical-field iron-core electromagnet are separated and supported by steel supports that form the "walls", "ceiling" and "floor" of the room-sized magnet. This provides an unimpeded 360° access to the magnet's imaging gap. The electromagnet coil elements are windings of multiple turns of epoxy-insulated copper installed around the poles of the magnet frame, connected to a regulated power source, and chilled via the closed loop chiller system.
During operation, the poles of the magnet establish a vertical magnet field with a limited fringe field. The magnetic field is created by passing a regulated DC current through the coil windings surrounding the magnet poles. The field strength is proportional to the amount of current in the coils. In this magnet the current supplied will result in a magnetic field of 6000 gauss, ± 5% (0.6T ± 5%), operating at frequencies between 24.27 and 26.92 MHz. This magnet functions with all imaging sequences available in the current software releases. All other non-magnet related equipment and procedures used are as previously reviewed by the FDA in PMA 830076, its supplements, and the 510(k) submissions K910839 and K951681.
| MAGNET CONFIGURATIONS | |||
|---|---|---|---|
| Magnet Specification | B3000 Permanent Magnet | QUAD 12000 Electromagnet | FONAR 360° Electromagnet |
| Type | Permanent Magnet | Iron-core Electromagnet | Iron-core Electromagnet |
| Field Strength | $0.3 T \pm 10%$ | $0.6 T \pm 5%$ | $0.6 T \pm 5%$ |
| Calculated SAR | .19 W/kg | 0.76 W/kg | 0.76 W/kg |
| Power Consumption | N/A | 98 KVA | 98 KVA |
| Magnet Coil Winding Material | |||
| (Each Pole) | N/A | Copper Bar | |
| with hollow core cooling | Copper Bar | ||
| with hollow core cooling | |||
| Cooling | N/A | 30 ton closed loop liquid chiller | 30 ton closed loop liquid chiller |
| Stability | |||
| (magnet drift) | long-term |