510(k) · Cleared
ClearedOpen Breast Coil (Obc) with Biopsy Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 28, 2005 as substantially equivalent to K022007 (Usa Instruments, Inc., 2002) after a 99-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 28, 2005
- Review
- 99 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931544 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 5 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- 4 generations backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
- 3 generations backK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- 2 generations backK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- 1 generation backK022007 Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2002
- This deviceK050728 Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −5 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −4 | K964626 | Edge/Vista System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1997 | 4 |
| −3 | K974844 | Outlook System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| −2 | K983342 | MR Guided Procedures (MRGP) Basic Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| −1 | K022007 | Liberty 5000 Breast Coil with Disposable Biopsy Plates | Usa Instruments, Inc. | 2002 | — |
| 0 (this device) | K050728 | Open Breast Coil (Obc) with Biopsy Plates | Usa Instruments, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K022007 | Liberty 5000 Breast Coil with Disposable Biopsy PlatesSummary page 2…0 Breast Coil with Disposable diagnostic purposes. The coil has a Biopsy Plate manufactured by USA Instruments, biopsy plate that allows access to the Inc. (K022007) breast. Indications for Use: Identical to routine -Similar to Liberty 5000 Breast Coil with Disposable MRI imaging.… | 2002 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K022007.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 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 Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner. The indications for use are the same as for standard imaging: The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons…
Read the full statement (130 words)
The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
The indications for use are the same as for standard imaging:
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050728: Open Breast Coil (Obc) with Biopsy Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050728
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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