510(k) · Cleared
Cleared1.5T Gem RT Open Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Coils (Usa Instruments, Inc.) · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jan 11, 2013 as substantially equivalent to K103335 (GE Healthcare, 2011) after a 77-day review. Its family tree reaches back 10 generations to 1997. 5 of the 28 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jan 11, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971684 (1997). 25 ancestors in all, the oldest K962061 (1996). 2 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 · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 1 generation backK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011 · Recalled
- This deviceK123327 1.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013
- Descendant · cites it directly · 1 of its ownK143389 3.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015
- Descendant · 2 generations on · 0 of its ownK213687 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch /…Neocoil, LLC · 2022
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 5 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 4 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 3 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 1 generation backK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011 · Recalled
- This deviceK123327 1.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −5 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −4 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −3 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −2 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −1 | K103335 | Gem Option for 1.5 Mri Systems | GE Healthcare | 2011 | 3 |
| 0 (this device) | K123327 | 1.5T Gem RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2013 | — |
| +1 | K143389 | 3.0T GEM RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2015 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103335 | Gem Option for 1.5 Mri SystemsSummary page 1…esonance, Specialty Classification Names: 21 CER 892. 1000 - Magnetic resonance diagnostic device Product Code: 90M0S Predicate Device(s): K103335, GEM Option for 1.5T MRJ Systems Device Description: The 1.5T GEM RT Open Array is a receive only 8-… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143389 | 3.0T GEM RT Open Array | 2015 | 1 |
Has anything in its family been recalled? (5 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 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 · 5 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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 18 of the 25 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K143389 (Ge Healthcare Coils (Usa Instruments, Inc.), 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 RT Open Array Coil that is a part of the Oncology Suite is a receive-only RF
coil designed for use with 1.5T MRJ systems manufactured by GE Healthcare. The
indications for use include the head, neck, and brachial plexus anatomnies and vasculature
imaging. The nucleus excited is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123327: 1.5T Gem RT Open Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123327
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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