510(k) · Cleared
ClearedDynamic Shielding Radiation Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Biophysics, Inc. · JAI Couch, Radiation Therapy, Powered
Cleared on Sep 29, 1998 as substantially equivalent to K910971 (Siemens Medical Laboratories, Inc., 1991) after a 76-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 29, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910971 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910971 Z XT Radiation Therapy Treatment TableSiemens Medical Laboratories, Inc. · 1991
- This deviceK982446 Dynamic Shielding Radiation TableAmerican Biophysics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910971 | Z XT Radiation Therapy Treatment Table | Siemens Medical Laboratories, Inc. | 1991 | — |
| 0 (this device) | K982446 | Dynamic Shielding Radiation Table | American Biophysics, Inc. | 1998 | — |
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 JAI? 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 JAI device
- #1 K231612 Eve Patient Positioner Systemscore 7.9 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K910971 | Z XT Radiation Therapy Treatment TableSummary page 1…bly Classification Name: Powered Radiation Therapy Patient Support Assembly Device: Dynamic Shielding Radiation Table Predicate Devices: Siemens - ZXT Treatment Table - K910971 ) The Dynamic Radiation Table, is 2 PC-controlled table which permits total body radiation and incorporates a series of moving t… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K910971.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAI
61in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAI
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAI
1in 2024
MAUDE reports naming product code JAI, 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 | 2 | — | 1 | 4 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 61 | 0 | 2 |
| 2013 | 1 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.
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/K982446 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982446: Dynamic Shielding Radiation Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982446
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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