510(k) · Cleared
Cleared3.0T Prostate Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 23, 2005 as substantially equivalent to K926571 (Medrad, Inc., 1993) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Jun 23, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926571 (1993). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK926571 Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc. · 1993
- 1 generation backK971380 Medrad Flex Interface DeviceMedrad, Inc. · 1997
- This deviceK051349 3.0T Prostate Imaging SystemMedrad, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK060401 Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK243428 e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems…Dxtx Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020
- Descendant · cites it directly · 0 of its ownK063342 Medrad Ecoil Imaging System for PhilipsMedrad, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K060401Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006 · cites it directly1descendant
- K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorDxtx Medical, Inc. · 2025 · cites it directly0descendants
- K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020 · 2 generations on0descendants
- K063342Medrad Ecoil Imaging System for PhilipsMedrad, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926571 | Mrinnervu (R) Endorectal Prostate Coil BPX-15 | Medrad, Inc. | 1993 | — |
| −1 | K971380 | Medrad Flex Interface Device | Medrad, Inc. | 1997 | — |
| 0 (this device) | K051349 | 3.0T Prostate Imaging System | Medrad, Inc. | 2005 | — |
| +1 | K060401 | Medrad 3.0T Ecoil Imaging System | Medrad, Inc. | 2006 | — |
| +1 | K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G… | Dxtx Medical, Inc. | 2025 | — |
| +2 | K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Rapid Biomedical GmbH | 2020 | — |
| +1 | K063342 | Medrad Ecoil Imaging System for Philips | Medrad, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K926571 | Mrinnervu (R) Endorectal Prostate Coil BPX-15Summary page 1…Prostate Imaging System PREDICATE DEVICES: MEDRAD MRlnnervu Endorectal Prostate Coil with Probe Interface Device (K926571) MEDRAD Flex Interface Device (K971380) INTENDED USE: The 3.OT Prost… | 1993 |
| * | K971380 | Medrad Flex Interface DeviceSummary page 1…vu Endorectal Prostate Coil with Probe Interface Device (K926571) MEDRAD Flex Interface Device (K971380) INTENDED USE: The 3.OT Prostate Imaging System is a receive- only c… | 1997 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 company; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060401 (Medrad, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K926571.
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 3.OT Prostate Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate gland and surrounding pelvic tissue. The 3.OT Prostate Imaging System is intended for use with Siemens 3.OT Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051349: 3.0T Prostate Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051349
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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