510(k) · Cleared

Cleared

Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX

K013985510(k) TraditionalCleared Feb 1, 200260-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

Machnet BV · MOS Coil, Magnetic Resonance, Specialty

Cleared on Feb 1, 2002 as substantially equivalent to K003340 (Mri Devices Corp., 2000) after a 60-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Feb 1, 2002
Review: 60 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003340 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003340 Obc-149 Breast Array CoilMri Devices Corp. · 2000
This deviceK013985 Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXXMachnet BV · 2002
Descendant · cites it directly · 0 of its ownK052045 Access Breast CoilConfirma, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K052045Access Breast CoilConfirma, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003340	Obc-149 Breast Array Coil	Mri Devices Corp.	2000	—
0 (this device)	K013985	Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX	Machnet BV	2002	—
+1	K052045	Access Breast Coil	Confirma, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K013985, 2000–2005Source: 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
*	K003340	Obc-149 Breast Array Coil Summary page 1 …rray Assembly 2. Equivalent legally marketed device: This device is similar in design and identical in function to the MRI Devices Corp. Model OBC-149 Breast Array Coil K003340 3. Indications for Use (intended use):. The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunct…	Mri Devices Corp.	2000	—

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
K052045	Access Breast Coil	Confirma, Inc.	2005	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 no recall.
Of its descendants, K052045 (Confirma, Inc., 2005) has gone furthest, with 0 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?

The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013985 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013985: Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013985

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026