510(k) · Cleared
ClearedSimondr DRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simondr, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 5, 2010 as substantially equivalent to K091435 (Canon, Inc., 2009) after a 116-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Apr 5, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K981556 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK091435 Digital Radiography Model Cxdi-55GCanon, Inc. · 2009 · Recalled
- This deviceK093790 Simondr DRPSimondr, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K091435 | Digital Radiography Model Cxdi-55G | Canon, Inc. | 2009 | 1 |
| 0 (this device) | K093790 | Simondr DRP | Simondr, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K091435 | Digital Radiography Model Cxdi-55G Our OCR of the scanned summary read K091345, FDA’s number for Gopher Gold Catheter, Model 5620 (Vascular Solutions, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Canon CXDI-55G”. | 2009 |
| * | — | Kodak (Carestream) Lanex Screen/AGFA Y2 Speed Film Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K091435.
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. 2010, 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?
The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.
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/K093790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093790: Simondr DRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093790
Report an extraction error
Are you the manufacturer?
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