510(k) · Cleared
ClearedGemini Iii Hybrid TX/RX 4 Channel Head Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 17, 2003 as substantially equivalent to K021262 (Usa Instruments, Inc., 2002) after a 72-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 17, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932271 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK932271 Magnetic Reson Diag Device Magnetom Project 016Siemens Medical Solutions USA, Inc. · 1994
- 1 generation backK021262 Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc. · 2002
- This deviceK033235 Gemini Iii Hybrid TX/RX 4 Channel Head CoilUsa Instruments, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932271 | Magnetic Reson Diag Device Magnetom Project 016 | Siemens Medical Solutions USA, Inc. | 1994 | — |
| −1 | K021262 | Magnetom Symphony Quadrature TX/RX Head Coil | Usa Instruments, Inc. | 2002 | — |
| 0 (this device) | K033235 | Gemini Iii Hybrid TX/RX 4 Channel Head Coil | Usa Instruments, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 MOS? 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 |
|---|---|---|---|
| * | K021262 | Magnetom Symphony Quadrature TX/RX Head CoilSummary page 2…se: Imaging of the brain, -Similar to the Magnetom Trio 3.OT Head Coil cervical spine, soft tissue of the head manufactured by USA Instruments, Inc. (K021262) and neck, Indications for Use: Identical to routine -Similar to the Magnetom Trio 3.OT Head Coil MR] imaging… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K021262.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.OT scanner manufactured by Siemens Medical Solutions, Inc. Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck Nuclei…
Read the full statement (164 words)
The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.OT scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.OT MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033235: Gemini Iii Hybrid TX/RX 4 Channel Head Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033235
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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