510(k) · Cleared
Recalled · Class II · 2017Legacy/Legacy-D Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IXR Table, Radiographic, Tilting
Cleared on Oct 16, 1997 after a 63-day review. The FDA summary names no predicate by number. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 16, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- IXR
- Recalls
- 4
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK973039 Legacy/Legacy-D TableGE Medical Systems · 1997
- Descendant · cites it directly · 4 of its ownK011624 Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001 · Recalled
- Descendant · 2 generations on · 3 of its ownK081091 Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · Recalled
- Descendant · 3 generations on · 2 of its ownK110785 Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · Recalled
- Descendant · 4 generations on · 1 of its ownK133553 KalareToshiba America Medical Systems, In.C · 2014 · Recalled
- Descendant · 5 generations on · 0 of its ownK143281 Ultimax-iToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 5 of 5 · See all- K011624Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001 · cites it directly4descendants
- K081091Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · 2 generations on3descendants
- K110785Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · 3 generations on2descendants
- K133553KalareToshiba America Medical Systems, In.C · 2014 · 4 generations on1descendant
- K143281Ultimax-iToshibamedical Systems Corporation · 2015 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973039 | Legacy/Legacy-D Table | GE Medical Systems | 1997 | — |
| +1 | K011624 | Expedio 500D R&F X-Ray System | GE Medical Systems | 2001 | 11 |
| +2 | K081091 | Precision 500D R&F X-Ray System | GE Healthcare | 2008 | 9 |
| +3 | K110785 | Kalare Diagnostic X-Ray Table System | Toshiba Medical Systems Coporation, Japan | 2011 | 1 |
| +4 | K133553 | Kalare | Toshiba America Medical Systems, In.C | 2014 | 3 |
| +5 | K143281 | Ultimax-i | Toshibamedical Systems Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 IXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011624 | Expedio 500D R&F X-Ray System | 2001 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| 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… |
| 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… |
| Jan 2, 2008 | Not classified | Z-1611-2008 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011624 (GE Medical Systems, 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IXR devicesIXR Table, Radiographic, Tilting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXR
FDA has decided no IXR device since 2007.
Median 510(k) review, days · IXR
Too few IXR 510(k)s in any year since 2007 to give a median.
Recalls per year · IXR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXR
1in 2024
MAUDE reports naming product code IXR, 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 | 0 | — | 1 | 4 |
| 2008 | 0 | — | 4 | 8 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 5 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 164 |
| 2013 | 0 | — | 0 | 196 |
| 2014 | 0 | — | 0 | 120 |
| 2015 | 0 | — | 0 | 82 |
| 2016 | 0 | — | 1 | 58 |
| 2017 | 0 | — | 1 | 25 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.
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/K973039 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973039: Legacy/Legacy-D Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973039
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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