510(k) · Cleared
Recalled · Class II · 2018Radrex-I, SW V4.00 Model Drad-3000E
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 Oct 9, 2012 as substantially equivalent to K082494 (Toshiba America Medical Systems, In.C, 2008) and 1 other predicate after a 22-day review. Its family tree reaches back 5 generations to 1994. It has been recalled 3 times.
- Decided
- Oct 9, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931071 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 4 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 3 generations backK073165 Drad-3000E, Radrex-IToshiba America Medical Systems, In.C · 2007 · Recalled
- 2 generations backK082494 DRAD3000E/Radrex-IToshiba America Medical Systems, In.C · 2008
- 1 generation backK083503 DRAD30003/Radrex-IToshiba America Medical Systems, In.C · 2009 · Recalled
- This deviceK122842 Radrex-I, SW V4.00 Model Drad-3000EToshiba America Medical Systems, In.C · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −4 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −3 | K073165 | Drad-3000E, Radrex-I | Toshiba America Medical Systems, In.C | 2007 | 1 |
| −2 | K082494 | DRAD3000E/Radrex-I | Toshiba America Medical Systems, In.C | 2008 | — |
| −1 | K083503 | DRAD30003/Radrex-I | Toshiba America Medical Systems, In.C | 2009 | 1 |
| 0 (this device) | K122842 | Radrex-I, SW V4.00 Model Drad-3000E | Toshiba America Medical Systems, In.C | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K082494 | DRAD3000E/Radrex-ISummary page 1…ger) 10. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 11. PREDICATE DEVICE: Toshiba RADREX-i (DRAD-3000E), v2.31: K082494 Toshiba RADREX-i, (DRAD-3000E), v3.0: K083503 12. REASON FOR SUBMISSION: Modification of a cleared device… | 2008 |
| * | K083503 | DRAD30003/Radrex-ISummary page 1…pter J, Federal Diagnostic X-ray Equipment Standard 11. PREDICATE DEVICE: Toshiba RADREX-i (DRAD-3000E), v2.31: K082494 Toshiba RADREX-i, (DRAD-3000E), v3.0: K083503 12. REASON FOR SUBMISSION: Modification of a cleared device… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2018 | Class II | Z-1958-2019 | Software design | software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It… |
| Apr 18, 2018 | Class II | Z-2964-2018 | Software design | It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK… |
| Mar 23, 2017 | Class II | Z-3111-2017 | Software design | It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K082494.
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. 2012, 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 as stated in the FDA summary.
https://510kreport.com/device/K122842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122842: Radrex-I, SW V4.00 Model Drad-3000E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122842
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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