510(k) · Cleared
ClearedSonic Shot GX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nemoto Kyorindo Co., Ltd. · IZQ Injector, Contrast Medium, Automatic
Cleared on May 21, 2010 as substantially equivalent to K984088 (Mallinckrodt Inc., Liebel-Flarsheim Business, 1999) and 1 other predicate after a 344-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 21, 2010
- Review
- 344 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012950 (2001). 5 ancestors in all, the oldest K935668 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
- 2 generations backK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
- 1 generation backK042784 Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004
- This deviceK091734 Sonic Shot GXNemoto Kyorindo Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012950 | Modification to: Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2001 | — |
| −2 | K033247 | Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2003 | — |
| −1 | K042784 | Medrad Spectris Solaris EP MR Injector System | Medrad, Inc. | 2004 | — |
| 0 (this device) | K091734 | Sonic Shot GX | Nemoto Kyorindo Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 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 IZQ? 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 IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 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 |
|---|---|---|---|
| * | K984088 | Optistar MR Injector SystemSummary page 1…Name: Injector System Classification Name: Injector and Syringe, Angiographic Predicate Device(s): Optistar MR Injector System (K984088) Medrad Spectris Solaris MR Injector System (K042784) Intended Use: The contrast delivery syste… | 1999 |
| * | K042784 | Medrad Spectris Solaris EP MR Injector SystemSummary page 1…d Syringe, Angiographic Predicate Device(s): Optistar MR Injector System (K984088) Medrad Spectris Solaris MR Injector System (K042784) Intended Use: The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration… | 2004 |
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 9 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 4 other devices also cite its predicate K984088.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, 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 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091734: Sonic Shot GX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091734
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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