510(k) · Cleared
Recalled · Class II · 2013Kalare Diagnostic X-Ray Table System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems Coporation, Japan · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on May 27, 2011 as substantially equivalent to K081091 (GE Healthcare, 2008) after a 67-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- May 27, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862120 (1986). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 2 generations backK011624 Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001 · Recalled
- 1 generation backK081091 Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · Recalled
- This deviceK110785 Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011
- Descendant · cites it directly · 1 of its ownK133553 KalareToshiba America Medical Systems, In.C · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK143281 Ultimax-iToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −2 | K011624 | Expedio 500D R&F X-Ray System | GE Medical Systems | 2001 | 11 |
| −1 | K081091 | Precision 500D R&F X-Ray System | GE Healthcare | 2008 | 9 |
| 0 (this device) | K110785 | Kalare Diagnostic X-Ray Table System | Toshiba Medical Systems Coporation, Japan | 2011 | — |
| +1 | K133553 | Kalare | Toshiba America Medical Systems, In.C | 2014 | 3 |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K081091 | Precision 500D R&F X-Ray SystemSummary page 2…KALARE (DREX-KLSO) 11. SUBSTANTIAL EQUIVALENCE: The KALARE (OREX-KL8O) is of comparable type and is substantially equivalent to the GE Precision 500D R&F X-ray (K081091). 12. SAFETY: The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 a… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133553 | Kalare | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2013 | Class II | Z-1598-2013 | Component design/selection | Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K133553 (Toshiba America Medical Systems, In.C, 2014) has gone furthest, with 1 descendant 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. 2011, 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?
1. Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
2. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects 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/K110785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110785: Kalare Diagnostic X-Ray Table System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110785
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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