510(k) · Cleared
ClearedNORMA 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odin Technologies, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 18, 1999 as substantially equivalent to K963186 (Inner Vision Mri, Ltd., 1996) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jun 18, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911642 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK911642 MRP-5000 and MRP-7000 Multiplanar ReconstructionHitachi Medical Systems America, Inc. · 1991
- This deviceK991243 NORMA 10Odin Technologies, Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK020601 Flexicoil - Malleable Receive-Only Surface CoilOdin Medical Technologies, Ltd. · 2002
Most influential descendants
Showing 1 of 1 · See all- K020601Flexicoil - Malleable Receive-Only Surface CoilOdin Medical Technologies, Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911642 | MRP-5000 and MRP-7000 Multiplanar Reconstruction | Hitachi Medical Systems America, Inc. | 1991 | — |
| 0 (this device) | K991243 | NORMA 10 | Odin Technologies, Ltd. | 1999 | — |
| +1 | K020601 | Flexicoil - Malleable Receive-Only Surface Coil | Odin Medical Technologies, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 |
|---|---|---|---|
| * | K963186 | ORTHO 8000Summary page 3…e: LNH - Magnetic Resonance Imaging System 807.92(a)(3) — Predicate Devices: Medical Device Applicant 510(k) Number | Classification Name Name Ortho 8000 Inner Vision K963186 Class |l device MRP-5000 Hitachi K911642 Class Il device Additional Substantial Equivalence Information is provided in the atta… | 1996 |
| * | K911642 | MRP-5000 and MRP-7000 Multiplanar ReconstructionSummary page 3…807.92(a)(3) — Predicate Devices: Medical Device Applicant 510(k) Number | Classification Name Name Ortho 8000 Inner Vision K963186 Class |l device MRP-5000 Hitachi K911642 Class Il device Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Ta… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020601 | Flexicoil - Malleable Receive-Only Surface Coil | 2002 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K020601 (Odin Medical Technologies, Ltd., 2002) has gone furthest, with 0 descendants of its own.
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 NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2)…
Read the full statement (111 words)
The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
• Anatomical regions: extremities and selected sections of the head.
• Nuclei excited: H-1
• Diagnostic uses: T1, T2, T2* and density weighted imaging.
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/K991243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991243: NORMA 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991243
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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