510(k) · Cleared
ClearedGE 0.2T Signa Profile/I MR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 10, 2003 as substantially equivalent to K992135 (Ge Medical Systems, Inc., 1999) after a 10-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Oct 10, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992135 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK992135 Signa Profile/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
- This deviceK033168 GE 0.2T Signa Profile/I MR SystemGeneral Electric Co. · 2003
- Descendant · cites it directly · 0 of its ownK043112 GE 0.2T Signa Profile Excite MR SystemGeneral Electric Co. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K043112GE 0.2T Signa Profile Excite MR SystemGeneral Electric Co. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992135 | Signa Profile/I Magnetic Resonance System | Ge Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K033168 | GE 0.2T Signa Profile/I MR System | General Electric Co. | 2003 | — |
| +1 | K043112 | GE 0.2T Signa Profile Excite MR System | General Electric Co. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K992135 | Signa Profile/I Magnetic Resonance SystemSummary page 1…, 21 CFR 892.1000, 90-LNH Marketed Device: The 0.2T Signa ProfileA MR System is substantially equivalent to the currently marketed the 0.2T Signa Profileh MR system (K992135) with the main differences being increasing the hardware capability of the Gradients to a slew rate of SR42, and the introductio… | 1999 |
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 |
|---|---|---|---|
| K043112 | GE 0.2T Signa Profile Excite MR System | 2004 | 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?
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 Signa Profile/i MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i with High Slew Rate Option MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The…
Read the full statement (170 words)
The Signa Profile/i MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i with High Slew Rate Option MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i MR system 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 (Ti), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Profileh with High Slew Rate Option MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033168 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033168: GE 0.2T Signa Profile/I MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033168
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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