510(k) · Cleared
ClearedMedrad Spectris Solaris EP MR Injector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Dec 10, 2004 as substantially equivalent to K033247 (Medrad, Inc., 2003) after a 65-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 10, 2004
- Review
- 65 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012950 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
- 1 generation backK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
- This deviceK042784 Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK143538 MRXperion MR Injection System, MRXperion MR Injection System Syringe…Bayer Medical Care, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK252891 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK091734 Sonic Shot GXNemoto Kyorindo Co., Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc. · 2015 · cites it directly2descendants
- K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc. · 2018 · 2 generations on1descendant
- K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…Bayer Medical Care, Inc. · 2026 · 3 generations on0descendants
- K091734Sonic Shot GXNemoto Kyorindo Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012950 | Modification to: Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2001 | — |
| −1 | K033247 | Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2003 | — |
| 0 (this device) | K042784 | Medrad Spectris Solaris EP MR Injector System | Medrad, Inc. | 2004 | — |
| +1 | K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2015 | 1 |
| +2 | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2018 | — |
| +3 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit… | Bayer Medical Care, Inc. | 2026 | — |
| +1 | K091734 | Sonic Shot GX | Nemoto Kyorindo Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 DXT? 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 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 |
|---|---|---|---|
| * | K033247 | Medrad Spectris Solaris MR Injector SystemSummary page 1…Medrad Spectris Sald PM Injector System (3T Compatible) Injector (K033247) Predicate _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 2003 |
What descends from it? (4)
2 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 3 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143538 (Bayer Medical Care, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K033247.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042784: Medrad Spectris Solaris EP MR Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042784
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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