510(k) · Cleared
Cleared1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
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 Jan 31, 2020 as substantially equivalent to K060401 (Medrad, Inc., 2006) and 1 other predicate after a 235-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 31, 2020
- Review
- 235 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K926571 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK926571 Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc. · 1993
- 3 generations backK971380 Medrad Flex Interface DeviceMedrad, Inc. · 1997
- 2 generations backK051349 3.0T Prostate Imaging SystemMedrad, Inc. · 2005
- 1 generation backK060401 Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006
- This deviceK191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926571 | Mrinnervu (R) Endorectal Prostate Coil BPX-15 | Medrad, Inc. | 1993 | — |
| −3 | K971380 | Medrad Flex Interface Device | Medrad, Inc. | 1997 | — |
| −2 | K051349 | 3.0T Prostate Imaging System | Medrad, Inc. | 2005 | — |
| −1 | K060401 | Medrad 3.0T Ecoil Imaging System | Medrad, Inc. | 2006 | — |
| 0 (this device) | K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Rapid Biomedical GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K060401 | Medrad 3.0T Ecoil Imaging SystemSummary page 6…ially equivalent to the cleared PREDICATE DEVICE which is described in the following submission. PREDICATE DEVICE Clearance Number Date MEDRAD 3.0T eCoil Imaging System K060401 03/15/2006 MEDRAD 1.5T Pelvic Imaging System Interface Device K053042 11/17/2005 Summary of Technological Characteristics of t… | 2006 |
| * | K053042 | Medrad 1.5T Pelvic Imaging System Interface DeviceSummary page 6…he following submission. PREDICATE DEVICE Clearance Number Date MEDRAD 3.0T eCoil Imaging System K060401 03/15/2006 MEDRAD 1.5T Pelvic Imaging System Interface Device K053042 11/17/2005 Summary of Technological Characteristics of the SuBJECT DEVICE as compared with the PREDICATE DEVICE The proposed la… | 2005 |
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 27 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Endorectal Coil is indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, displaying the internal structure of the prostate. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
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/K191539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191539: 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191539
Report an extraction error
Are you the manufacturer?
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