510(k) · Cleared
ClearedInkSpace Imaging Small 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 20, 2024 as substantially equivalent to K233444 (Inkspace Imaging, Inc., 2024) after a 23-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Dec 20, 2024
- Review
- 23 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K041185 (2004). No later device cites it as a predicate yet.
- Root · 7 generations backK041185 Torso Array Coil, Model 558GE-64Igc-Medical Advances, Inc. · 2004
- 6 generations backK063513 Echelon MR-RCC-150 Cardiac CoilHitachi Medical Systems America, Inc. · 2006
- 5 generations backK081340 Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
- 4 generations backK101949 Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
- 3 generations backK213397 InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021
- 2 generations backK223487 InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022
- 1 generation backK233444 InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
- This deviceK243675 InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K041185 | Torso Array Coil, Model 558GE-64 | Igc-Medical Advances, Inc. | 2004 | — |
| −6 | K063513 | Echelon MR-RCC-150 Cardiac Coil | Hitachi Medical Systems America, Inc. | 2006 | — |
| −5 | K081340 | Pediatric Body and Cardiac Coil, Model 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008 | — |
| −4 | K101949 | Pediatric Body-Cardiac Coil, Model: 5000012601 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010 | — |
| −3 | K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021 | — |
| −2 | K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022 | — |
| −1 | K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024 | — |
| 0 (this device) | K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K233444 | InkSpace Imaging Small Body ArraySummary page 6…Name: InkSpace Imaging Small Body Array Generic/Common Name: Coil, Magnetic Resonance, Specialty PREDICATE DEVICE(S) [807.92(A)(3)] InkSpace Imaging Small Body Array (K233444) DEVICE DESCRIPTION [807.92(A)(4)] The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work… | 2024 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K233444.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T 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/K243675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243675: InkSpace Imaging Small 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/K243675
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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