510(k) · Cleared

Cleared

1.5T Pediatric Head and Spine Array Model

K060689510(k) SpecialCleared Mar 31, 200616-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Resonance Innovations, LLC · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 31, 2006 as substantially equivalent to K951649 (Medic, Inc., 1995) after a 16-day review. Its family tree reaches back 1 generation to 1995.

Decided: Mar 31, 2006
Review: 16 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951649 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951649 Model #801GE1500 Pediatric Array CoilMedic, Inc. · 1995
This deviceK060689 1.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951649	Model #801GE1500 Pediatric Array Coil	Medic, Inc.	1995	—
0 (this device)	K060689	1.5T Pediatric Head and Spine Array Model	Resonance Innovations, LLC	2006	—

FIG. 1 — Lineage of K060689, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K951649	Model #801GE1500 Pediatric Array Coil Summary page 1 …ication: Class 1I/Radiology/LNH 3. Unmodified Device Trade Name: 1.5T Pediatric Array #801GE1500 Unmodified Device 510(k) No.: k951649. 4. Device Description: The 1.5T Pediatric Head and Spine Array, Catalog #808GE 1500, interfaces with the G.E. 1.5 Tesla…	Medic, Inc.	1995	—

Also cleared against K951649: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K951649.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)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?

Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.

Magnetic resonance angiography.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060689 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060689: 1.5T Pediatric Head and Spine Array Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060689

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