# K994287: Fonar 360 Degree Magnetic Resonance Imaging Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Fonar Corp.
- Decided: Mar 16, 2000 after 87 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951681 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P830076: Fonar NMR Whole Body Scanner Beta 3000, Fonar Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P830076/S001 (Jul 10, 1985). Summary page 1.
- K951681: Quad 1200 Magnetic Resonance Imaging Scanner, Fonar Corp. (1995) Summary page 1.

## 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 (spin-lattice 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.

Source page: https://510kreport.com/device/K994287
Methodology: https://510kreport.com/methodology