510(k) · Cleared
ClearedFonar 360 Degree Magnetic Resonance Imaging Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fonar Corp. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 16, 2000 as substantially equivalent to K951681 (Fonar Corp., 1995) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 16, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951681 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951681 Quad 1200 Magnetic Resonance Imaging ScannerFonar Corp. · 1995
- This deviceK994287 Fonar 360 Degree Magnetic Resonance Imaging ScannerFonar Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951681 | Quad 1200 Magnetic Resonance Imaging Scanner | Fonar Corp. | 1995 | — |
| 0 (this device) | K994287 | Fonar 360 Degree Magnetic Resonance Imaging Scanner | Fonar Corp. | 2000 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P830076 | Fonar NMR Whole Body Scanner Beta 3000 FDA lists this PMA only through its supplements; the earliest we hold is P830076/S001 (Jul 10, 1985). Summary page 1…e 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 th… | |
| * | K951681 | Quad 1200 Magnetic Resonance Imaging ScannerSummary page 1…M 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 inten… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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…
Read the full statement (213 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994287: Fonar 360 Degree Magnetic Resonance Imaging Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994287
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026