510(k) · Cleared
Recalled · Class II · 2024FLUOROspeed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corporation · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Aug 5, 2019 as substantially equivalent to K190373 (Shimadzu Corporation, 2019) after a 21-day review. Its family tree reaches back 8 generations to 1986. It has been recalled 2 times.
- Decided
- Aug 5, 2019
- Review
- 21 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K862120 (1986). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 3 generations backK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- 2 generations backK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- 1 generation backK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- This deviceK191877 FLUOROspeedShimadzu Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −3 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| −2 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| −1 | K190373 | SonialVision G4 | Shimadzu Corporation | 2019 | 2 |
| 0 (this device) | K191877 | FLUOROspeed | Shimadzu Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 2 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K190373 | SonialVision G4Summary page 4…ntensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Common/Usual Name: Fluoroscopic x-ray system 2. Equivalent legally marketed device: K190373 Trade/Device Name: SONIALVISION G4 Manufacturer: Shimadzu. Regulation Number: 21CFR892.1650 Regulation Name: Image-in… | 2019 |
| † | K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | 2018 |
| † | K081091 | Precision 500D R&F X-Ray System | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2024 | Class II | Z-0317-2025 | Software change control | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the… |
| Jan 10, 2022 | Class II | Z-0867-2022 | Software design | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- 8 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K190373.
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. 2019, 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 equipment 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 equipment is used for total patient population.
The equipment is NOT intended to be used for Mammography screening.
The equipment is NOT intended to be used for interventional procedure.
The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in the equipment 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/K191877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191877: FLUOROspeed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191877
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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