510(k) · Cleared
Recalled · 2011DRAD30003/Radrex-I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · KPR System, X-Ray, Stationary
Cleared on Feb 13, 2009 as substantially equivalent to K082494 (Toshiba America Medical Systems, In.C, 2008) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 13, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931071 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 3 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 2 generations backK073165 Drad-3000E, Radrex-IToshiba America Medical Systems, In.C · 2007 · Recalled
- 1 generation backK082494 DRAD3000E/Radrex-IToshiba America Medical Systems, In.C · 2008
- This deviceK083503 DRAD30003/Radrex-IToshiba America Medical Systems, In.C · 2009
- Descendant · cites it directly · 0 of its ownK122842 Radrex-I, SW V4.00 Model Drad-3000EToshiba America Medical Systems, In.C · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122842Radrex-I, SW V4.00 Model Drad-3000EToshiba America Medical Systems, In.C · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −3 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −2 | K073165 | Drad-3000E, Radrex-I | Toshiba America Medical Systems, In.C | 2007 | 1 |
| −1 | K082494 | DRAD3000E/Radrex-I | Toshiba America Medical Systems, In.C | 2008 | — |
| 0 (this device) | K083503 | DRAD30003/Radrex-I | Toshiba America Medical Systems, In.C | 2009 | — |
| +1 | K122842 | Radrex-I, SW V4.00 Model Drad-3000E | Toshiba America Medical Systems, In.C | 2012 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K082494 | DRAD3000E/Radrex-ISummary page 1…Fed. Reg. No. 892.1650, Pro. Code: 90MQB/KPR] T (per 21 CFR 892.1650) 21 CFR Subchapter J, ‘ Federal Diagnostic X-ray Equipment Standard Toshiba DRAD-3000E, RADREX-i [k082494] Philips Medical Systems Bucky Vision (Digital Diagnost) 510(k) Control Number: K982795 Modification to existing device The RAD… | 2008 |
| * | K982795 | Philips Bucky VisionSummary page 1…r J, ‘ Federal Diagnostic X-ray Equipment Standard Toshiba DRAD-3000E, RADREX-i [k082494] Philips Medical Systems Bucky Vision (Digital Diagnost) 510(k) Control Number: K982795 Modification to existing device The RADREX-I is a general purpose x-ray system that employs Solid State Imagex(s), SSXI, which… | 1998 |
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 |
|---|---|---|---|
| K122842 | Radrex-I, SW V4.00 Model Drad-3000E | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2011 | Not classified | Z-0941-2012 | Nonconforming Material/Component | It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K122842 (Toshiba America Medical Systems, In.C, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082494.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand (fixed detector only)-or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest; abdomen, spine, neck and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammegraphy, fluoroscopy and anglography studies.
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/K083503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083503: DRAD30003/Radrex-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083503
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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