510(k) · Cleared
Recalled · Class II · 2019Precision 500D R&F X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 11, 2008 as substantially equivalent to K011624 (GE Medical Systems, 2001) after a 56-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it. It has been recalled 9 times.
- Decided
- Jun 11, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862120 (1986). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 1 generation backK011624 Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001 · Recalled
- This deviceK081091 Precision 500D R&F X-Ray SystemGE Healthcare · 2008
- Descendant · cites it directly · 2 of its ownK110785 Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK133553 KalareToshiba America Medical Systems, In.C · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK143281 Ultimax-iToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −1 | K011624 | Expedio 500D R&F X-Ray System | GE Medical Systems | 2001 | 11 |
| 0 (this device) | K081091 | Precision 500D R&F X-Ray System | GE Healthcare | 2008 | — |
| +1 | K110785 | Kalare Diagnostic X-Ray Table System | Toshiba Medical Systems Coporation, Japan | 2011 | 1 |
| +2 | K133553 | Kalare | Toshiba America Medical Systems, In.C | 2014 | 3 |
| +3 | K143281 | Ultimax-i | Toshibamedical Systems Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K011624 | Expedio 500D R&F X-Ray SystemSummary page 1…m Class: Class II Product Code: JAA (3) Predicate Device: 510(k) Number: K011624 GE Model Name: Precision 500D R&F X-ray System (Previous N… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110785 | Kalare Diagnostic X-Ray Table System | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2019 | Class II | Z-1754-2019 | Device Design | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. |
| Feb 6, 2017 | Class II | Z-2179-2017 | Device Design | Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator. |
| Nov 21, 2016 | Class II | Z-0910-2017 | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Jun 12, 2015 | Class II | Z-1966-2015 | Nonconforming Material/Component | The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in… |
| Jun 12, 2015 | Class II | Z-2120-2015 | Nonconforming Material/Component | A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F… |
| Sep 5, 2014 | Class II | Z-0010-2015 | Employee error | GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging… |
| Dec 12, 2013 | Class II | Z-0911-2014 | Device Design | GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a… |
| Nov 8, 2013 | Class II | Z-0804-2014 | Employee error | Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of… |
| Aug 30, 2013 | Class II | Z-0012-2014 | Employee error | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K110785 (Toshiba Medical Systems Coporation, Japan, 2011) has gone furthest, with 2 descendants of its own.
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. 2008, 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 Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081091: Precision 500D R&F X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081091
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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