510(k) · Cleared
ClearedHead Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 8, 2019 as substantially equivalent to K163205 (Ge Healthcare Coils (Usa Instruments, Inc.), 2017) and 5 other predicates after an 81-day review. Its family tree reaches back 15 generations to 1997. 5 of the 55 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 8, 2019
- Review
- 81 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K971684 (1997). 54 ancestors in all, the oldest K951649 (1995). No later device cites it as a predicate yet. 5 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations between
- 3 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- 1 generation backK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
- This deviceK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
Show all 15 generations
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 11 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 9 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 8 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 7 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 6 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 5 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 4 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 3 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- 1 generation backK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
- This deviceK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −14 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −13 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −12 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −11 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −9 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −8 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −7 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −6 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −5 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −4 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −3 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −2 | K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | 2015 | 6 |
| −1 | K163205 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017 | — |
| 0 (this device) | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 1 |
| 2002 | 3 | 1 |
| 2003 | 3 | 1 |
| 2004 | 1 | 1 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (6)
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 |
|---|---|---|---|
| * | K163205 | 48CH Head CoilSummary page 4…Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K163205 Page 1 of 5 Shanghai United Imaging Healthcare Co., Ltd. T e… | 2017 |
| * | K181697 | 16ch Foot/ Ankle SPEEDERSummary page 5…ER Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K181697 Predicate Device 3 Manufacturer: INVIVO Device Name: CARDIOVASCULAR ARRAY COILS… | 2018 |
| * | K061952 | Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16Summary page 5…LS Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K061952 Predicate Device 4 Manufacturer: Resonance Innovations LLC Device Name: Orbit an… | 2006 |
| * | K133986 | 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArraySummary page 5…ly Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K133986 Predicate Device 5 Manufacturer: Shanghai Chenguang Medical Technologies Co., Ltd Device Name:… | 2014 |
| * | K112002 | Carotid CoilSummary page 5…il Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K112002 Predicate Device 6 Manufacturer: Quality Electrodynamics, LLC Device Name: Pedia… | 2011 |
| * | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilSummary page 5…il Product Code: MOS Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K140998 Page 2 of 5 Shanghai United Imaging Healthcare Co., Ltd. T… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 8 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 · 9 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 · 10 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 10 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 11 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 33 of the 54 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K163205.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained…
Read the full statement (359 words)
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Infant Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183186: Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183186
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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