510(k) · Cleared
ClearedPediatric Head-Spine Coil (Model:5000012701
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Chenguang Medical Technologies Co, Ltd. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 14, 2010 as substantially equivalent to K081322 (Shanghai Chenguang Medical Technologies Co, Ltd., 2008) after a 12-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 14, 2010
- Review
- 12 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003655 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003655 PHS-63 Pediatric Head and Spine Array CoilMri Devices Corp. · 2001
- 1 generation backK081322 Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric…Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
- This deviceK101858 Pediatric Head-Spine Coil (Model:5000012701Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K101858 | Pediatric Head-Spine Coil (Model:5000012701 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K081322 | Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine CoilSummary page 1…Predicate Devices (Legally Marketed Devices) Pediatric Head-Spine Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd. 510k number is K081322. Device Description The Pediatric Head-Spine Coil is an 8-channel phased array, receive-only coil. It consists of eight element… | 2008 |
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 7.4 years on median.
- 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. 2010, 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 Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 3.OT system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101858: Pediatric Head-Spine Coil (Model:5000012701.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101858
Report an extraction error
Are you the manufacturer?
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