510(k) · Cleared
ClearedAcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radmedix, LLC · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 12, 2023 as substantially equivalent to K210919 (Radmedix, LLC, 2021) after a 30-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Jul 12, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K896095 (1990). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations between
- 3 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 2 generations backK201058 Accuvue+Radmedix, LLC · 2020
- 1 generation backK210919 AcuityDReRadmedix, LLC · 2021
- This deviceK231709 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC · 2023
Show all 14 generations
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 13 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 12 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 11 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 10 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 9 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 8 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 7 generations backK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- 6 generations backK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- 5 generations backK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
- 4 generations backK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- 3 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 2 generations backK201058 Accuvue+Radmedix, LLC · 2020
- 1 generation backK210919 AcuityDReRadmedix, LLC · 2021
- This deviceK231709 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −13 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −12 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −11 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −10 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −9 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −8 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −7 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| −6 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
| −5 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017 | — |
| −4 | K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019 | — |
| −3 | K200726 | AcuityPDR | Radmedix, LLC | 2020 | — |
| −2 | K201058 | Accuvue+ | Radmedix, LLC | 2020 | — |
| −1 | K210919 | AcuityDRe | Radmedix, LLC | 2021 | — |
| 0 (this device) | K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K210919 | AcuityDReSummary page 4…Substantially equivalent device: Trade Name: AcuityDRe Manufacturer: RadmediX 510(k) #: K210919 Classification Name: Stationary x-ray system Classification Panel: Radiology Classification R… | 2021 |
| † | K210314 | Mars1717X Wireless Digital Flat Panel Detector | 2021 |
| † | K210316 | Mars 1417X Wireless Digital Flat Panel Detector | 2021 |
| † | K220668 | Wireless Digital Flat Panel Detector | 2022 |
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 33 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K210919.
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. 2023, 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?
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231709 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231709: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231709
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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