510(k) · Cleared
ClearedNexus DR Digital X-Ray Imaging System (with vSharp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varex Imaging Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 20, 2019 as substantially equivalent to K190146 (Varex Imaging Corporation, 2019) after a 25-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Dec 20, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K803130 (1981). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 8 generations between
- 3 generations backK172951 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and…Varex Imaging Corporation · 2017
- 2 generations backK183212 Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 2018
- 1 generation backK190146 Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2019
- This deviceK193238 Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation · 2019
Show all 12 generations
- Root · 12 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 11 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 9 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 8 generations backK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
- 7 generations backK103416 Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
- 6 generations backK130318 Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013
- 5 generations backK161459 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed · 2016
- 4 generations backK171138 Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2017
- 3 generations backK172951 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and…Varex Imaging Corporation · 2017
- 2 generations backK183212 Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 2018
- 1 generation backK190146 Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2019
- This deviceK193238 Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −11 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −10 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −9 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −8 | K093066 | I5 Digital X-Ray Imaging System, Model I5 | Infimed, Inc. | 2010 | — |
| −7 | K103416 | Nexus DRF Digital X-Ray Imaging System | Infimed, Inc. | 2011 | — |
| −6 | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013 | — |
| −5 | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | Varian Medical Systems, X-Ray Products-Infimed | 2016 | — |
| −4 | K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2017 | — |
| −3 | K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation | 2017 | — |
| −2 | K183212 | Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation | 2018 | — |
| −1 | K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2019 | — |
| 0 (this device) | K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | Varex Imaging Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K190146 | Nexus DR Digital X-ray Imaging SystemSummary page 4…tem Regulation: 21 CFR 892.1680 Classification Name: Stationary X-ray System Class: II Primary Product Code: MQB 510(k) Number: K190146 Device Description: The Nexus DR• Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system desi… | 2019 |
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 38 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 24 ancestors have a recall of any class.
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. 2019, 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 Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer.…
Read the full statement (130 words)
The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.
The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193238: Nexus DR Digital X-Ray Imaging System (with vSharp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193238
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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