510(k) · Cleared
ClearedGE Signa MR Oncology Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 22, 2008 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) after a 15-day review. Its family tree reaches back 5 generations to 1996. 4 of the 15 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Jul 22, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962061 (1996). 11 ancestors in all. 3 later devices descend from it, 1 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 4 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 3 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 2 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 1 generation backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- This deviceK081916 GE Signa MR Oncology PackageGe Medical Systems, LLC · 2008
- Descendant · cites it directly · 2 of its ownK102155 MR Radiation Oncology OptionsGe Medical Systems, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK123091 Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TImris, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK121997 Imris Oncology PackageImris, Inc. · 2012
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…3 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology3 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System4 generations back · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −4 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −3 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −2 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −1 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| 0 (this device) | K081916 | GE Signa MR Oncology Package | Ge Medical Systems, LLC | 2008 | — |
| +1 | K102155 | MR Radiation Oncology Options | Ge Medical Systems, LLC | 2010 | — |
| +2 | K123091 | Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T | Imris, Inc. | 2012 | — |
| +2 | K121997 | Imris Oncology Package | Imris, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K052293 | GE 1.5T and 3.0T Signa HDX MR SystemSummary page 1…ng System Classification Name: Magnetic Resonance Diagnostic Device, (21 C.F.R. 892.1000, LNH) Predicate Devices: GE 1.5T and 3.OT Signal' HDx MR System (K052293) Device Description: The GE Signal' MR Oncology Package includes a patient table that can be used with a GE Signal MR System and… | 2005 |
| † | K080072 | Mri Patient Positioning Devices | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102155 | MR Radiation Oncology Options | 2010 | 2 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K102155 (Ge Medical Systems, LLC, 2010) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K052293.
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. 2008, this device’s year, is highlighted.
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 GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems. The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR system with Signa® MR Oncology Package is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique…
Read the full statement (250 words)
The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems.
The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR system with Signa® MR Oncology Package is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vssel and musculaskeletaJ regions of the body. The images produced by the Signa® MR system with Signa ® MR Oncology Package reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The Signa® MR Oncology Package provides an additional patient table for Signa m 0 MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa ® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient _iurfarp- uich as X-RAv; rT, PET, and radiation therapy. The Signa ® MR system with Siena ® MR Oncology Packajge may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081916: GE Signa MR Oncology Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081916
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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