510(k) · Cleared
ClearedSentinelle Endo Coil Array for Pelvic Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinelle Medical, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 18, 2011 as substantially equivalent to K053042 (Medrad, Inc., 2005) after a 286-day review. Its family tree reaches back 2 generations to 1998. 19 of the 219 devices in its family, counting itself, have a Class I recall. 216 later devices descend from it.
- Decided
- Aug 18, 2011
- Review
- 286 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974438 (1998). 216 later devices descend from it, 1 citing it directly. 19 of the 219 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK974438 Medrad Atd-T Interface DeviceMedrad, Inc. · 1998
- 1 generation backK053042 Medrad 1.5T Pelvic Imaging System Interface DeviceMedrad, Inc. · 2005
- This deviceK103274 Sentinelle Endo Coil Array for Pelvic ImagingSentinelle Medical, Inc. · 2011
- Descendant · cites it directly · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 3 generations on · 85 of its ownK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 84 of its ownK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 216 · See all- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · cites it directly215descendants
- K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on115descendants
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc. · 2015 · 3 generations on85descendants
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on84descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 2 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974438 | Medrad Atd-T Interface Device | Medrad, Inc. | 1998 | — |
| −1 | K053042 | Medrad 1.5T Pelvic Imaging System Interface Device | Medrad, Inc. | 2005 | — |
| 0 (this device) | K103274 | Sentinelle Endo Coil Array for Pelvic Imaging | Sentinelle Medical, Inc. | 2011 | — |
| +1 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| +2 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +3 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| +3 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| +2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2013 | 11 | 2 |
| 2014 | 7 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 1 |
| 2017 | 15 | 1 |
| 2018 | 18 | 2 |
| 2019 | 19 | 1 |
| 2020 | 21 | 3 |
| 2021 | 9 | 1 |
| 2022 | 21 | 2 |
| 2023 | 25 | 3 |
| 2024 | 18 | 0 |
| 2025 | 20 | 1 |
| 2026 | 19 | 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.
19 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K053042 | Medrad 1.5T Pelvic Imaging System Interface DeviceSummary page 1…gnetic Resonance Diagnostic Device, Class It as described in 21 CFR 892.1000 Product Code: MOS Predicate Devices: K053042 - MEDRAD 1.ST Pelvic Imaging System Interface Device Device Description: The Endo Coil Array is a reusable, rigid transrectal or… | 2005 |
What descends from it? (216)
See all 2161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio Class I | 2012 | 215 |
Has anything in its family been recalled? (19 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
- K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121434 (Siemens Medi Cal Solutions, Inc., 2012) has gone furthest, with 215 descendants of its own.
- 2 other devices also cite its predicate K053042.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103274: Sentinelle Endo Coil Array for Pelvic Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103274
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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