510(k) · Cleared
ClearedPHS-63 Pediatric Head and Spine Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corp. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 2, 2001 after a 67-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 2, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK003655 PHS-63 Pediatric Head and Spine Array CoilMri Devices Corp. · 2001
- Descendant · cites it directly · 1 of its ownK081322 Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric…Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK101858 Pediatric Head-Spine Coil (Model:5000012701Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK071847 Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP -…Shanghai Chenguang Medical Technologies Co, Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See all- K081322Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine CoilShanghai Chenguang Medical Technologies Co, Ltd. · 2008 · cites it directly1descendant
- K101858Pediatric Head-Spine Coil (Model:5000012701Shanghai Chenguang Medical Technologies Co, Ltd. · 2010 · 2 generations on0descendants
- K071847Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle CoilShanghai Chenguang Medical Technologies Co, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003655 | PHS-63 Pediatric Head and Spine Array Coil | Mri Devices Corp. | 2001 | — |
| +1 | K081322 | Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine… | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008 | — |
| +2 | K101858 | Pediatric Head-Spine Coil (Model:5000012701 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010 | — |
| +1 | K071847 | Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle… | Shanghai Chenguang Medical Technologies Co, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K081322 (Shanghai Chenguang Medical Technologies Co, Ltd., 2008) 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.
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 | — |
https://510kreport.com/device/K003655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003655: PHS-63 Pediatric Head and Spine Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003655
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026