510(k) · Cleared
Recalled · Class II · 2014Gem Option for 1.5 Mri Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 7, 2011 as substantially equivalent to K091536 (Ge Medical Systems, LLC, 2009) after a 112-day review. Its family tree reaches back 9 generations to 1997. 5 of the 28 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 7, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K971684 (1997). 24 ancestors in all, the oldest K962061 (1996). 3 later devices descend from it, 1 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 2 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- This deviceK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011
- Descendant · cites it directly · 2 of its ownK123327 1.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013
- Descendant · 2 generations on · 1 of its ownK143389 3.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015
- Descendant · 3 generations on · 0 of its ownK213687 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch /…Neocoil, LLC · 2022
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 3 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 2 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- This deviceK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013 · cites it directly2descendants
- K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015 · 2 generations on1descendant
- K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −3 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −2 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −1 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| 0 (this device) | K103335 | Gem Option for 1.5 Mri Systems | GE Healthcare | 2011 | — |
| +1 | K123327 | 1.5T Gem RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2013 | — |
| +2 | K143389 | 3.0T GEM RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2015 | — |
| +3 | K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR… | Neocoil, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 1 |
| 2002 | 2 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 1 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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.
5 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K091536 | Optima MR450WSummary page 1…Name: Magnetic resonance diagnostic device Classification Names: 21 CFR 892. 1000 Product Code: 9OLNH, 90M0S Predicate Device(s): K091536, Optima MR45Ow Page 5-2… | 2009 |
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 |
|---|---|---|---|
| K123327 | 1.5T Gem RT Open Array | 2013 | 2 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2014 | Class II | Z-1533-2014 | Process design | GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or… |
| Apr 2, 2014 | Class II | Z-1480-2014 | Process change control | Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to… |
| Apr 12, 2012 | Not classified | Z-1492-2012 | Nonconforming Material/Component | GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. If a second and compounding issue… |
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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 17 of the 24 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K123327 (Ge Healthcare Coils (Usa Instruments, Inc.), 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K091536.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for 1.5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103335: Gem Option for 1.5 Mri Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103335
Report an extraction error
Are you the manufacturer?
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