510(k) · Cleared

Recalled · Class II · 2024

Biopsy Breast Coil, Model BBC

K032576510(k) SpecialCleared Oct 23, 200364-day reviewClass II21 CFR 892.1000Recalls 4

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

Mri Devices Corp. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Oct 23, 2003 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it. It has been recalled 4 times.

Decided: Oct 23, 2003
Review: 64 days
Class: Class II
Product code: MOS
Recalls: 4
Predicates: 0

21 later devices descend from it, 4 citing it directly.

This deviceK032576 Biopsy Breast Coil, Model BBCMri Devices Corp. · 2003
Descendant · cites it directly · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
Descendant · 2 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
Descendant · 3 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
Descendant · 3 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
Descendant · 4 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2004high 4 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 21 · See all

K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 2 generations on9descendants
K092954Cadstream Version 5Confirma, Inc. · 2009 · 3 generations on8descendants
K170195QuantXQuantitative Insights, Inc. · 2017 · 3 generations on4descendants
K210670BU-CADTaihao Medical, Inc. · 2021 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032576	Biopsy Breast Coil, Model BBC	Mri Devices Corp.	2003	—
+1	K041286	Dynacad V1.0	Mri Devices Corp.	2004	—
+2	K081556	Cadstream, Version 5.0	Confirma, Inc.	2009	—
+3	K092954	Cadstream Version 5	Confirma, Inc.	2009	3
+3	K170195	QuantX	Quantitative Insights, Inc.	2017	—
+4	K210670	BU-CAD	Taihao Medical, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	4	0
2012	1	0
2014	1	0
2017	1	0
2018	2	0
2019	2	0
2021	1	0
2023	2	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K032576, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (21)

See all 21

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041286	Dynacad V1.0	Mri Devices Corp.	2004	17
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 Breast Coil…	Philips Medical Systems Nederland B.V.	2026	0
K122646	DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0T	Invivo Corporation	2012	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 4, 2024	Class II	Z-0536-2025	Use error	Potential safety issue where a patient may be harmed while preparing for or during a scan.
Nov 4, 2024	Class II	Z-0539-2025	Use error	Potential safety issue where a patient may be harmed while preparing for or during a scan.
Nov 4, 2024	Class II	Z-0542-2025	Use error	Potential safety issue where a patient may be harmed while preparing for or during a scan.
Nov 4, 2024	Class II	Z-0540-2025	Use error	Potential safety issue where a patient may be harmed while preparing for or during a scan.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K041286 (Mri Devices Corp., 2004) has gone furthest, with 17 descendants of its own.

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?

To be used in conjunction with a Magnetic Resonance Scanner to:

1) Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

2) Permit MR-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K032576 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032576: Biopsy Breast Coil, Model BBC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032576

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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