510(k) · Cleared
ClearedPediatric Body and Cardiac Coil, Model 01000140201
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 Jun 18, 2008 as substantially equivalent to K063513 (Hitachi Medical Systems America, Inc., 2006) after a 36-day review. Its family tree reaches back 2 generations to 2004. 6 later devices descend from it.
- Decided
- Jun 18, 2008
- Review
- 36 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041185 (2004). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK041185 Torso Array Coil, Model 558GE-64Igc-Medical Advances, Inc. · 2004
- 1 generation backK063513 Echelon MR-RCC-150 Cardiac CoilHitachi Medical Systems America, Inc. · 2006
- This deviceK081340 Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
- Descendant · cites it directly · 5 of its ownK101949 Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
- Descendant · 2 generations on · 4 of its ownK213397 InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK223487 InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK233444 InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK253182 InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101949Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010 · cites it directly5descendants
- K213397InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021 · 2 generations on4descendants
- K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022 · 3 generations on3descendants
- K233444InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024 · 4 generations on2descendants
- K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041185 | Torso Array Coil, Model 558GE-64 | Igc-Medical Advances, Inc. | 2004 | — |
| −1 | K063513 | Echelon MR-RCC-150 Cardiac Coil | Hitachi Medical Systems America, Inc. | 2006 | — |
| 0 (this device) | K081340 | Pediatric Body and Cardiac Coil, Model 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008 | — |
| +1 | K101949 | Pediatric Body-Cardiac Coil, Model: 5000012601 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010 | — |
| +2 | K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021 | — |
| +3 | K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022 | — |
| +4 | K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024 | — |
| +5 | K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K063513 | Echelon MR-RCC-150 Cardiac CoilSummary page 1…Marketed Devices) A predicate device for the 0100040201-AP Pediatric Cardiac Body coil 1.5T is the Echelon MR-RCC-150 Coil, manufactured by Hitachi and cleared under K063513 and also the Model PHS-63 Pediatric Head Spine Array Coil, manufactured by MRI Devices. Device Description The Model 0100040… | 2006 |
| * | — | Model PHS-63 Pediatric Head Spine Array Coil Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101949 | Pediatric Body-Cardiac Coil, Model: 5000012601 | 2010 | 5 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101949 (Shanghai Chenguang Medical Technologies Co, Ltd., 2010) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K063513.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081340: Pediatric Body and Cardiac Coil, Model 01000140201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081340
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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