510(k) · Cleared
ClearedX-Ray TV System Sonial Vision G4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Mar 28, 2014 as substantially equivalent to K052500 (Shimadzu Medical Systems, 2005) after a 345-day review. Its family tree reaches back 2 generations to 2005. 6 later devices descend from it.
- Decided
- Mar 28, 2014
- Review
- 345 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050925 (2005). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK050925 Digital Radiography System Radspeed SafireShimadzu Corp. · 2005
- 1 generation backK052500 DAR-8000FShimadzu Medical Systems · 2005 · Recalled
- This deviceK131075 X-Ray TV System Sonial Vision G4Shimadzu Corp. · 2014
- Descendant · cites it directly · 5 of its ownK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK212212 Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022
- Descendant · 4 generations on · 0 of its ownK221281 Multitom RaxSiemens Medical Solutions · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK212145 DR 800 with DSA, DR 800Agfa N.V. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142341X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · cites it directly5descendants
- K190373SonialVision G4Shimadzu Corporation · 2019 · 2 generations on4descendants
- K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022 · 3 generations on1descendant
- K221281Multitom RaxSiemens Medical Solutions · 2022 · 4 generations on0descendants
- K212145DR 800 with DSA, DR 800Agfa N.V. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050925 | Digital Radiography System Radspeed Safire | Shimadzu Corp. | 2005 | — |
| −1 | K052500 | DAR-8000F | Shimadzu Medical Systems | 2005 | 2 |
| 0 (this device) | K131075 | X-Ray TV System Sonial Vision G4 | Shimadzu Corp. | 2014 | — |
| +1 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| +2 | K190373 | SonialVision G4 | Shimadzu Corporation | 2019 | 2 |
| +3 | K212212 | Multitom Rax with True2scale Body Scan Option | Siemens Medical Solutions | 2022 | — |
| +4 | K221281 | Multitom Rax | Siemens Medical Solutions | 2022 | 1 |
| +3 | K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 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? (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 |
|---|---|---|---|
| * | K052500 | DAR-8000FSummary page 1…CFR Section 21 CFR§892.1650 Device Class Class 11 Product Code 90 JAA 6) Legally Marketed Predicate Device IK052500 IDAR-800OF U9HIMADZU 510(k) Notification Submission, SONIALVISION G4… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142341 | X-Ray TV System Sonialvision G4 | 2015 | 5 |
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 8.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K142341 (Shimadzu Corp., 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K052500.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
The system is used for total patient population.
This system is NOT intended to be used for Mammography screening.
This system is NOT intended to be used for interventional procedure,
This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131075: X-Ray TV System Sonial Vision G4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131075
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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