510(k) · Cleared
ClearedCrystal 5000 Phases Array TMJ 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 13, 2001 as substantially equivalent to K944773 (Medical Advances, Inc., 1995) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 13, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944773 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944773 Model 405GE-64: Phased Array TMJ CoilMedical Advances, Inc. · 1995
- This deviceK013528 Crystal 5000 Phases Array TMJ CoilUsa Instruments, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944773 | Model 405GE-64: Phased Array TMJ Coil | Medical Advances, Inc. | 1995 | — |
| 0 (this device) | K013528 | Crystal 5000 Phases Array TMJ Coil | Usa Instruments, Inc. | 2001 | — |
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? (2)
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 |
|---|---|---|---|
| * | K944773 | Model 405GE-64: Phased Array TMJ CoilSummary page 2…roducts Intended Use: Imaging of the temporo-mandibular joint, condyle, and mandible. ~ Similar to 405GE-64 Phased Array TMJ Coil manufactured by IGC Medical Advances (K944773) -Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) Indications for Use: Identical… | 1995 |
| * | K001210 | HI-Res 9000 Phased Array Carotid CoilSummary page 2…r to 405GE-64 Phased Array TMJ Coil manufactured by IGC Medical Advances (K944773) -Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) Indications for Use: Identical to routine MRI imaging -Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by US… | 2000 |
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?
- None of the 2 ancestors has a recall.
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 Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner. Anatomic Regions: Temporo-mandibular Joint Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as an NMR…
Read the full statement (133 words)
The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.
Anatomic Regions: Temporo-mandibular Joint
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Marconi Medical Systems Proview 0.23Tesla 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013528: Crystal 5000 Phases Array TMJ Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013528
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026