510(k) · Cleared
Recalled · 2009Drad-3000E, 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 Nov 16, 2007 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) after a 7-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 16, 2007
- Review
- 7 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931071 (1994). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 1 generation backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- This deviceK073165 Drad-3000E, Radrex-IToshiba America Medical Systems, In.C · 2007
- Descendant · cites it directly · 2 of its ownK082494 DRAD3000E/Radrex-IToshiba America Medical Systems, In.C · 2008
- Descendant · 2 generations on · 1 of its ownK083503 DRAD30003/Radrex-IToshiba America Medical Systems, In.C · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK122842 Radrex-I, SW V4.00 Model Drad-3000EToshiba America Medical Systems, In.C · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K082494DRAD3000E/Radrex-IToshiba America Medical Systems, In.C · 2008 · cites it directly2descendants
- K083503DRAD30003/Radrex-IToshiba America Medical Systems, In.C · 2009 · 2 generations on1descendant
- K122842Radrex-I, SW V4.00 Model Drad-3000EToshiba America Medical Systems, In.C · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −1 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| 0 (this device) | K073165 | Drad-3000E, Radrex-I | Toshiba America Medical Systems, In.C | 2007 | — |
| +1 | K082494 | DRAD3000E/Radrex-I | Toshiba America Medical Systems, In.C | 2008 | — |
| +2 | K083503 | DRAD30003/Radrex-I | Toshiba America Medical Systems, In.C | 2009 | 1 |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K982795 | Philips Bucky VisionSummary page 1…f (per 21 CFR 892.1650) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Philips Medical Systems Bucky Vision (Digital Diagnost) 510(k) Contro! Number: K982795 New device The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays direc… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082494 | DRAD3000E/Radrex-I | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2009 | Not classified | Z-1177-2010 | Component design/selection | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K082494 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 2 descendants 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. 2007, 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. It is 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, fluoroscopy and angiography 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/K073165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073165: Drad-3000E, Radrex-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073165
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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