510(k) · Cleared
ClearedDRAD3000E/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 · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 12, 2008 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931071 (1994). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 2 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK073165 Drad-3000E, Radrex-IToshiba America Medical Systems, In.C · 2007 · Recalled
- This deviceK082494 DRAD3000E/Radrex-IToshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 1 of its ownK083503 DRAD30003/Radrex-IToshiba America Medical Systems, In.C · 2009 · Recalled
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −2 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −1 | K073165 | Drad-3000E, Radrex-I | Toshiba America Medical Systems, In.C | 2007 | 1 |
| 0 (this device) | K082494 | DRAD3000E/Radrex-I | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K083503 | DRAD30003/Radrex-I | Toshiba America Medical Systems, In.C | 2009 | 1 |
| +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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K982795 | Philips Bucky VisionSummary page 1…r J, _ Federal Diagnostic X-ray Equipment Standard Toshiba DRAD-3000E, RADREX-i [k073165] Philips Medical Systems Bucky Vision (Digital Diagnost) 510(k) Control Number: K982795 Modification to existing device The RADREX-[ is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which… | 1998 |
| * | K073165 | Drad-3000E, Radrex-ISummary page 1…[Fed. Reg. No. 892.1650, Pro. Code: S0MQB/KPR] Tffer 21 CFR 892.1650) 21 CFR Subchapter J, _ Federal Diagnostic X-ray Equipment Standard Toshiba DRAD-3000E, RADREX-i [k073165] Philips Medical Systems Bucky Vision (Digital Diagnost) 510(k) Control Number: K982795 Modification to existing device The RAD… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K083503 (Toshiba America Medical Systems, In.C, 2009) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K982795.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
This device is Indicated as a general radiography device. 1tis capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, flucroscopy and angiography studes.
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/K082494 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082494: DRAD3000E/Radrex-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082494
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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