510(k) · Cleared

Cleared

Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems

K060873510(k) TraditionalCleared Apr 14, 200615-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

Sentinelle Medical, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Apr 14, 2006 as substantially equivalent to K993776 (Mri Devices Corp., 1999) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1999. 19 of the 233 devices in its family, counting itself, have a Class I recall. 229 later devices descend from it.

Decided: Apr 14, 2006
Review: 15 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K993776 (1999). 3 ancestors in all. 229 later devices descend from it, 3 citing it directly. 19 of the 233 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
This deviceK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
Descendant · cites it directly · 227 of its ownK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
Descendant · 2 generations on · 220 of its ownK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
Descendant · 3 generations on · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
Descendant · 4 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
Descendant · 5 generations on · 85 of its ownK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)

Showing 5 of 229 descendants. See all descendants

Descendants cleared per year

2010high 27 (2023) · low 1 (2010)2026

Class I recalls in this family

K121434 Software Syngo MR D13A for the Magnetom Systems…3 generations on · 2012
K181613 MAGNETOM Avanto, MAGNETOM Verio with software…4 generations on · 2018
K130885 Magnetom Avanto-Fit, Magnetom Skyra-Fit4 generations on · 2013
K132119 Magnetom Prisma, Magnetom Prisma Fit5 generations on · 2013

Most influential descendants

Showing 5 of 229 · See all

K100113Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…Sentinelle Medical, Inc. · 2010 · cites it directly227descendants
K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on220descendants
K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations on215descendants
K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on115descendants
K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc. · 2015 · 5 generations on85descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993776	Obc-300 Breast Array Coil	Mri Devices Corp.	1999	—
0 (this device)	K060873	Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE…	Sentinelle Medical, Inc.	2006	—
+1	K100113	Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri…	Sentinelle Medical, Inc.	2010	1
+2	K111242	Magnetom Aera and Magnetom Skyra	Siemens Medical Solutions USA, Inc.	2011	3
+3	K121434	Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio	Siemens Medi Cal Solutions, Inc.	2012	Class I
+4	K141977	Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo…	Siemens Medical Solutions USA, Inc.	2014	—
+5	K151579	MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM…	Siemens Medical Solutions USA, Inc.	2015	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	0
2012	2	1
2013	12	2
2014	8	0
2015	7	1
2016	5	1
2017	15	1
2018	18	2
2019	19	1
2020	22	3
2021	9	1
2022	24	2
2023	27	3
2024	18	0
2025	20	1
2026	20	0

FIG. 1 — Lineage of K060873, 1999–2026Source: 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.

19 devices in this family have a Class I recall. 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? (3)

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
*	K993776	Obc-300 Breast Array Coil Summary page 1 …act Person: Cameron Piron, President Date of Preparation: Dec 3 1st, 2005 B. Predicate Device: (Model OBC-300 Breast Array Coil, MRI Devices Corp, K993776) with (Breast Immobilization and Biopsy Device MR-Biopsy 160, MRI Devices Corp, K010570) C. Establishment…	Mri Devices Corp.	1999	—
*	K010570	Breast Immobiization and Biopsy Device MR-Biopsy 160 Summary page 1 …Device: (Model OBC-300 Breast Array Coil, MRI Devices Corp, K993776) with (Breast Immobilization and Biopsy Device MR-Biopsy 160, MRI Devices Corp, K010570) C. Establishment Registration #: Applied for and Pending Manufacture Facility Location: Sentinelle Medical I…	Mri Devices Corp.	2001	—
*	K041481	Model BBC-127 Biopsy Breast Coil Summary page 3 …n to predicate device or other 8 Channel Coil Array 510K cleared products Indications for Use: The Same intended indications for use as K041481 - Sentinelle Vanguard Breast BBC-127 as indicated: MRI Auxiliary Table with 8 Indications for Use: To b…	Mri Devices Corp.	2004	1
†	K013485	Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional…	Microlife Corp.	2002	—
†	K032045	8 Channel Cardiac Phased Array Coil	GE Medical Systems	2003	—
†	K041695	Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate	Usa Instruments, Inc.	2004	5
†	K041476	GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System	Ge Medical Systems, LLC	2004	Class I

Also cleared against K993776: 1 other device →

What descends from it? (229)

See all 229

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

Number	Device	Applicant	Decided	Descendants
K100113	Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…	Sentinelle Medical, Inc.	2010	227
K130262	Magnetom Essenza with Syngo MR D14	Siemens Medical Solutions USA, Inc.	2013	11
K142002	Breast Speeder CX, Grid Holder CX	Quality Electrodynamics, LLC	2014	0

Has anything in its family been recalled? (19 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls

Nearest 12 of 19 shown.

Nearest 5 of 19; all are on the web page.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K100113 (Sentinelle Medical, Inc., 2010) has gone furthest, with 227 descendants of its own.
1 other device also cites its predicate K993776.

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?

The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images can be interpreted by a trained physician. When used with the disposable sterile plate the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060873: Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060873

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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