510(k) · Cleared

Cleared

dS Breast Coil 7ch 1.5T

K232762510(k) SpecialCleared Oct 3, 202325-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

Invivo Corporation (Business Trade Name: Philips) · MOS Coil, Magnetic Resonance, Specialty

Cleared on Oct 3, 2023 as substantially equivalent to K032576 (Mri Devices Corp., 2003) after a 25-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Oct 3, 2023
Review: 25 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032576 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK032576 Biopsy Breast Coil, Model BBCMri Devices Corp. · 2003 · Recalled
This deviceK232762 dS Breast Coil 7ch 1.5TInvivo Corporation (Business Trade Name: Philips) · 2023
Descendant · cites it directly · 0 of its ownK262330 dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast…Philips Medical Systems Nederland B.V. · 2026

Most influential descendants

Showing 1 of 1 · See all

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…Philips Medical Systems Nederland B.V. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032576	Biopsy Breast Coil, Model BBC	Mri Devices Corp.	2003	4
0 (this device)	K232762	dS Breast Coil 7ch 1.5T	Invivo Corporation (Business Trade Name: Philips)	2023	—
+1	K262330	dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS…	Philips Medical Systems Nederland B.V.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K232762, 2003–2026Source: 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
*	K032576	Biopsy Breast Coil, Model BBC Summary page 4 …Review Panel: Radiology Device Class: Class II Product Code: MOS Predicate Device Trade Name: Biopsy Breast Coil BBC (K032576 - October 23, 2003) Predicate Classification Name: Coil, Magnetic Resonance Predicate Regulation Number: 21 CFR 892.1000 Predicat…	Mri Devices Corp.	2003	4

Also cleared against K032576: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K262330	dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…	Philips Medical Systems Nederland B.V.	2026	0

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 a recall.
Of its descendants, K262330 (Philips Medical Systems Nederland B.V., 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K032576.

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. 2023, this device’s year, is highlighted.

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?

The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CS, Prodiva 1.5T CX and a MR 5300 1.5T Magnetic Resonance Scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232762: dS Breast Coil 7ch 1.5T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232762

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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