510(k) · Cleared
ClearedInkSpace Imaging Pediatric Body Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inkspace Imaging, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 17, 2021 as substantially equivalent to K101949 (Shanghai Chenguang Medical Technologies Co, Ltd., 2010) after a 60-day review. Its family tree reaches back 4 generations to 2004. 4 later devices descend from it.
- Decided
- Dec 17, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041185 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK041185 Torso Array Coil, Model 558GE-64Igc-Medical Advances, Inc. · 2004
- 3 generations backK063513 Echelon MR-RCC-150 Cardiac CoilHitachi Medical Systems America, Inc. · 2006
- 2 generations backK081340 Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
- 1 generation backK101949 Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
- This deviceK213397 InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK223487 InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK233444 InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK253182 InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243675 InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022 · cites it directly3descendants
- K233444InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024 · 2 generations on2descendants
- K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc. · 2025 · 3 generations on0descendants
- K243675InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041185 | Torso Array Coil, Model 558GE-64 | Igc-Medical Advances, Inc. | 2004 | — |
| −3 | K063513 | Echelon MR-RCC-150 Cardiac Coil | Hitachi Medical Systems America, Inc. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021 | — |
| +1 | K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022 | — |
| +2 | K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024 | — |
| +3 | K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025 | — |
| +3 | K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K101949 | Pediatric Body-Cardiac Coil, Model: 5000012601Summary page 4…Coil, Magnetic Resonance, Specialty Classification: Class II per 21 CFR§892.1000 Product Code: MOS PREDICATE DEVICE(S) [807.92(a)(3)] Pediatric Body-Cardiac Coil (K101949) 2 5.0 510(k) SUMMARY (CONT.) DEVICE DESCRIPTION [80… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223487 | InkSpace Imaging Body Array | 2022 | 3 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223487 (Inkspace Imaging, Inc., 2022) has gone furthest, with 3 descendants 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. 2021, 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 Ink:Space Imaging Pediatric Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. 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/K213397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213397: InkSpace Imaging Pediatric Body Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213397
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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