510(k) · Cleared
Recalled · Class II · 2020Kalare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 13, 2014 as substantially equivalent to K110785 (Toshiba Medical Systems Coporation, Japan, 2011) after a 206-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jun 13, 2014
- Review
- 206 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862120 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 3 generations backK011624 Expedio 500D R&F X-Ray SystemGE Medical Systems · 2001 · Recalled
- 2 generations backK081091 Precision 500D R&F X-Ray SystemGE Healthcare · 2008 · Recalled
- 1 generation backK110785 Kalare Diagnostic X-Ray Table SystemToshiba Medical Systems Coporation, Japan · 2011 · Recalled
- This deviceK133553 KalareToshiba America Medical Systems, In.C · 2014
- Descendant · cites it directly · 0 of its ownK143281 Ultimax-iToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K143281Ultimax-iToshibamedical Systems Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −3 | 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 |
| −1 | K110785 | Kalare Diagnostic X-Ray Table System | Toshiba Medical Systems Coporation, Japan | 2011 | 1 |
| 0 (this device) | K133553 | Kalare | Toshiba America Medical Systems, In.C | 2014 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110785 | Kalare Diagnostic X-Ray Table SystemSummary page 2…rd Page 327 of 329 7. PREDICATE DEVICE: KALARE (DREX-KL8O) , K1 10785 8. REASON FOR SUBMISSION: Modification of a cleared device 9. SUBMISSION TYPE: Traditional 51 0(k) 10. DEVICE DESCRIPT… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143281 | Ultimax-i | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2020 | Class II | Z-1101-2021 | Other | GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient… |
| Sep 12, 2017 | Class II | Z-0012-2018 | Software design | During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. |
| Jan 14, 2016 | Class II | Z-1175-2016 | Radiation Control for Health and Safety Act | When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K143281 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 0 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. 2014, 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 prone or supine position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133553: Kalare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133553
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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