510(k) · Cleared
ClearedInfant Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Imaging Research Dba Sree Medical Systems · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 29, 2012 as substantially equivalent to K052621 (Usa Instruments, Inc., 2005) and 1 other predicate after a 135-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 29, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001870 (2000). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001870 Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 2000
- 3 generations backK032618 3.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
- 2 generations backK052916 Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005 · Recalled
- 1 generation backK093348 3.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009
- This deviceK113365 Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012
- Descendant · cites it directly · 1 of its ownK140998 Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See all- K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014 · cites it directly1descendant
- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001870 | Millennium 9000 Phased Array Neurovascular Coil | Usa Instruments, Inc. | 2000 | — |
| −3 | K032618 | 3.0T 8 Channel Neurovascular (NV) Array Coil | Usa Instruments, Inc. | 2003 | — |
| −2 | K052916 | Usa Instruments 3.0T Brain/Spine Array | Usa Instruments, Inc. | 2005 | 1 |
| −1 | K093348 | 3.0T 16 Channel Head Neck Spine Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009 | — |
| 0 (this device) | K113365 | Infant Array | Advanced Imaging Research Dba Sree Medical Systems | 2012 | — |
| +1 | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | Quality Electrodynamics, LLC | 2014 | — |
| +2 | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K052621 | 1.5T 16 Channel Brain-Spine Array CoilSummary page 3…rray for GE, Siemens, Philips 1.5T and 3.OT MRI Scanners 10. Comparison to Predicate: 1.ST 16 Channel GE Brain Spine Array (K052621) 3.01 16 Channel GE Head Neck Spine Array (K093348) In general, the Infant Array is… | 2005 |
| * | K093348 | 3.0T 16 Channel Head Neck Spine CoilSummary page 3…nners 10. Comparison to Predicate: 1.ST 16 Channel GE Brain Spine Array (K052621) 3.01 16 Channel GE Head Neck Spine Array (K093348) In general, the Infant Array is similar in use to the above-mentioned adult sized head neck spine arrays and is conside… | 2009 |
| † | K023929 | Magnetic Resonance Diagnostic Device | 2003 |
| † | K083541 | Neonate Head and Body Coils | 2009 |
| † | K083539 | Infant Cardiac Array | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | 2014 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K140998 (Quality Electrodynamics, LLC, 2014) 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. 2012, 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 Infant Array when used in conjunction with GE, Siemens and Philips 1.51 and 3T1 MRI systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MLRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113365: Infant Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113365
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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