510(k) · Cleared
Cleared16CH AI Breast Coils 1.5 T and 3 T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Biomedical GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 21, 2008 as substantially equivalent to K973630 (Siemens Medical Solutions USA, Inc., 1997) after a 17-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Nov 21, 2008
- Review
- 17 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973630 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973630 CP Breast Array Coil/Magnetom Harmony/Symphony SystemSiemens Medical Solutions USA, Inc. · 1997
- This deviceK083255 16CH AI Breast Coils 1.5 T and 3 TRapid Biomedical GmbH · 2008
- Descendant · cites it directly · 0 of its ownK181948 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilRapid Biomedical GmbH · 2018
Most influential descendants
Showing 1 of 1 · See all- K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilRapid Biomedical GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973630 | CP Breast Array Coil/Magnetom Harmony/Symphony System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K083255 | 16CH AI Breast Coils 1.5 T and 3 T | Rapid Biomedical GmbH | 2008 | — |
| +1 | K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Rapid Biomedical GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K973630 | CP Breast Array Coil/Magnetom Harmony/Symphony SystemSummary page 2…lowing submission: PredicateDevice Name FDA ClearanceNumber FDA ClearanceDate CP BREAST ARRAY COIL K973630 12/05/1997 Summary of Technological Characteristics of the Principal Device as compared wit… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | 2018 | 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, K181948 (Rapid Biomedical GmbH, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 16 Ch Al Breast Coil 1.5 T and the 16 Ch Al Breast Coil 3 T are indicated
for use as a diagnostic imaging device accessory to produce transverse, sagittal,
coronal and oblique images, spectroscopic images and/or spectra, and that
displays the internal structure of the breast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083255: 16CH AI Breast Coils 1.5 T and 3 T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083255
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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