510(k) · Cleared
ClearedToshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.)
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 Oct 7, 1999 as substantially equivalent to K771298 (Toshiba Medical Systems, 1977) after a 27-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Oct 7, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771298 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK771298 6 L.L. SystemToshiba Medical Systems · 1977
- This deviceK993038 Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.)Toshiba America Medical Systems, In.C · 1999
- Descendant · cites it directly · 0 of its ownK041027 Digital Radiography System with Flat Panel Detector, Model DFP8000DToshibamedical Systems Corporation · 2004
Most influential descendants
Showing 1 of 1 · See all- K041027Digital Radiography System with Flat Panel Detector, Model DFP8000DToshibamedical Systems Corporation · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771298 | 6 L.L. System | Toshiba Medical Systems | 1977 | — |
| 0 (this device) | K993038 | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.) | Toshiba America Medical Systems, In.C | 1999 | — |
| +1 | K041027 | Digital Radiography System with Flat Panel Detector, Model DFP8000D | Toshibamedical Systems Corporation | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K771298 | 6 L.L. SystemSummary page 1…tensified [Fed. Reg. No. 892.1650, Pro. Code: 90JAA] II (per 21 CFR 892.1650) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Toshiba 6” LI. System [K771298] Modification of cleared device The J-Advanced LL, Model RTP9211J-G11 is a modification to a previously cleared device, 6” LL… | 1977 |
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 |
|---|---|---|---|
| K041027 | Digital Radiography System with Flat Panel Detector, Model DFP8000D | 2004 | 0 |
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.
- Of its descendants, K041027 (Toshibamedical Systems Corporation, 2004) 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.
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 Toshiba J-Advanced LI. is designed to capture x-ray images on a phosphor, and convert the x-ray pattern into a corresponding light image of a higher energy density.
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/K993038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993038: Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993038
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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