510(k) Report

510(k) · Cleared

Cleared

Modification to: Medrad Spectris Solaris MR Injector System

K012950510(k) SpecialCleared Oct 4, 200130-day reviewClass II21 CFR 870.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medrad, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Oct 4, 2001 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Oct 4, 2001
Review
30 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2016: 1 descendant cleared2004: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
  3. Descendant · 2 generations on · 4 of its ownK042784 Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004
  4. Descendant · 3 generations on · 2 of its ownK143538 MRXperion MR Injection System, MRXperion MR Injection System Syringe…Bayer Medical Care, Inc. · 2015 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2018
  6. Descendant · 2 generations on · 1 of its ownK161471 MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12010: 12015: 12016: 12017: 12018: 12026: 1
2003high 2 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K033247Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003 · cites it directly7descendants
  • K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004 · 2 generations on4descendants
  • K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc. · 2015 · 3 generations on2descendants
  • K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc. · 2018 · 4 generations on1descendant
  • K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012950Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc.2001—
+1K033247Medrad Spectris Solaris MR Injector SystemMedrad, Inc.2003—
+2K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc.2004—
+3K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc.20151
+4K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc.2018—
+2K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
201010
201510
201610
201710
201810
202610
FIG. 1 — Lineage of K012950, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033247Medrad Spectris Solaris MR Injector SystemMedrad, Inc.20037
K031483Medrad Manual Syringe LoaderMedrad, Inc.20030

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?

  • Of its descendants, K033247 (Medrad, Inc., 2003) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DXT devices

DXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXT

1in 2025

2007: 32008: 22009: 62010: 12011: 42013: 22014: 62015: 72016: 82017: 72018: 92019: 42020: 32021: 12023: 12024: 42025: 12026 (partial year): 7
2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXT

138in 2024

2007: 182 days median2009: 137 days median2011: 69 days median2014: 144 days median2015: 153 days median2016: 172 days median2017: 183 days median2018: 93 days median2019: 96 days median2020: 154 days median2024: 138 days median2026 (partial year): 264 days median
2007high 264 (2026) · low 69 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXT

10in 2024

2007: 42008: 32009: 72010: 32011: 32012: 72015: 12018: 22020: 12021: 12023: 22024: 102026 (partial year): 6
2007high 10 (2024) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXT

97in 2025

2007: 1072008: 1682009: 1882010: 1242011: 1332012: 1352013: 1412014: 972015: 1352016: 1522017: 1282018: 1292019: 1212020: 932021: 1322022: 1112023: 1172024: 1182025: 97
2007high 188 (2009) · low 93 (2020)2025

MAUDE reports naming product code DXT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731824107
20082—3168
200961377188
20101—3124
20114693133
20120—7135
20132—0141
20146144097
201571531135
201681720152
201771830128
20189932129
20194960121
20203154193
20211—1132
20220—0111
20231—2117
2024413810118
20251—097
202672646—

What is it indicated for?

The Spectris Solaris MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography. Only trained healthcare professionals are intended to operate this device.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

Recent decisions in DXT

The DXT category page

  • K262043MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12)…Bayer Medical Care, Inc. · 2026
  • K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for…Fortis Biosolutions Company Limited · 2026
  • K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro…Acist Medical Systems, Inc. · 2026
  • K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single…Acist Medical Systems, Inc. · 2026
  • K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd. · 2026

https://510kreport.com/device/K012950 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012950: Modification to: Medrad Spectris Solaris MR Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012950

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026