510(k) Report

510(k) · Cleared

Cleared

Medrad Spectris Solaris MR Injector System

K033247510(k) SpecialCleared Nov 5, 200329-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 Nov 5, 2003 as substantially equivalent to K012950 (Medrad, Inc., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided
Nov 5, 2003
Review
29 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012950 (2001). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2004: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant clearedK012950 · Modification to: Medrad Spectris Solaris MR Injector System · Medrad, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K012950 · Modification to: Medrad Spectris Solaris MR Injector System · Medrad, Inc. · 20010
  1. Root · 1 generation backK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
  2. This deviceK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
  3. Descendant · cites it directly · 4 of its ownK042784 Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004
  4. Descendant · 2 generations on · 2 of its ownK143538 MRXperion MR Injection System, MRXperion MR Injection System Syringe…Bayer Medical Care, Inc. · 2015 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2018
  6. Descendant · cites it directly · 1 of its ownK161471 MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016
  7. Descendant · 4 generations on · 0 of its ownK252891 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12010: 12015: 12016: 12017: 12018: 12026: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004 · cites it directly4descendants
  • K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc. · 2015 · 2 generations on2descendants
  • K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc. · 2018 · 3 generations on1descendant
  • K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016 · cites it directly1descendant
  • K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…Bayer Medical Care, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012950Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc.2001—
0 (this device)K033247Medrad Spectris Solaris MR Injector SystemMedrad, Inc.2003—
+1K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc.2004—
+2K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc.20151
+3K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc.2018—
+1K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc.2016—
+4K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit…Bayer Medical Care, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201010
201510
201610
201710
201810
202610
FIG. 1 — Lineage of K033247, 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 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K012950Modification to: Medrad Spectris Solaris MR Injector System
Summary page 1
…Medrad Spectris Solaris MR Injector System PREDICATE DEVICE: Medrad Spectris Solaris MR Injector System (K012950) INTENDED USE: The Spectris Solaris MR Injection System is a syringe…
Medrad, Inc.2001—

Also cleared against K012950: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc.20044
K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc.20161

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?

  • Its one ancestor has no recall.
  • Of its descendants, K042784 (Medrad, Inc., 2004) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K012950.

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 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.

Also cleared against K012950

1 other device cites the same predicate.

  • K031483Medrad Manual Syringe LoaderMedrad, Inc. · 2003

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/K033247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033247: Medrad Spectris Solaris 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/K033247

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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