510(k) · Cleared
Recalled · Class II · 2019Expedio 500D R&F X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 8, 2001 as substantially equivalent to K862120 (General Electric Co., 1986) and 2 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1986. 4 later devices descend from it. It has been recalled 11 times.
- Decided
- Jun 8, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 1 generation to K862120 (1986). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- This deviceK011624 Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001
- Descendant · cites it directly · 3 of its ownK081091 Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK110785 Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK133553 KalareToshiba America Medical Systems, In.C · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK143281 Ultimax-iToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K081091Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · cites it directly3descendants
- K110785Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · 2 generations on2descendants
- K133553KalareToshiba America Medical Systems, In.C · 2014 · 3 generations on1descendant
- K143281Ultimax-iToshibamedical Systems Corporation · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| 0 (this device) | K011624 | Expedio 500D R&F X-Ray System | GE Medical Systems | 2001 | — |
| +1 | K081091 | Precision 500D R&F X-Ray System | GE Healthcare | 2008 | 9 |
| +2 | K110785 | Kalare Diagnostic X-Ray Table System | Toshiba Medical Systems Coporation, Japan | 2011 | 1 |
| +3 | K133553 | Kalare | Toshiba America Medical Systems, In.C | 2014 | 3 |
| +4 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K862120 | SCX SystemSummary page 2…In the opinion of GE Medical Systems, the Expedio 500D R&F X- ray System is substantially equivalent to the presently marketed Advantx Legacy/Legacy D R&F X-ray System (K862120 and K973039) and the InfiMed Patriot Digital System (K963037). The Expedio 500D does not include any new indications for use, nor… | 1986 |
| * | K963037 | PatriotSummary page 1…xaminations. The Expedio 500D R&F X-ray System is substantially equivalent to the Advantx Radiographic System (Originally cleared as the SCX KB862120), InfiMed Patriot (K963037) and the Legacy/Legacy D Table (K873039). The Expedio 500D R&F X-ray System will conform to applicable sections of 21CFR 1020.3… | 1996 |
| * | K973039 | Legacy/Legacy-D Table Our OCR of the scanned summary read K873039, FDA’s number for Model 820 Top=Trak (Sierra Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Legacy/Legacy D Table”. | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081091 | Precision 500D R&F X-Ray System | 2008 | 3 |
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 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… |
| May 2, 2013 | Class II | Z-1989-2013 | Device Design | GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension… |
| Jan 2, 2008 | Not classified | Z-1610-2008 | Nonconforming Material/Component | GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube… |
| Oct 4, 2007 | Not classified | Z-0369-2008 | Radiation Control for Health and Safety Act | It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a… |
| Aug 13, 2007 | Not classified | Z-1477-2008 | Radiation Control for Health and Safety Act | Necessary certification labels are missing from the x-ray contol. |
| Aug 1, 2007 | Not classified | Z-0274-2008 | Software design | Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console… |
| May 15, 2006 | Not classified | Z-1304-06 | Other | Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept… |
| Dec 30, 2004 | Not classified | Z-0220-05 | Other | Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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 Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011624: Expedio 500D R&F X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011624
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026