510(k) · Cleared
ClearedNexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, X-Ray Products-Infimed · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 6, 2016 as substantially equivalent to K992794 (Infimed, Inc., 1999) and 1 other predicate after a 103-day review. Its family tree reaches back 7 generations to 1981. 5 later devices descend from it.
- Decided
- Sep 6, 2016
- Review
- 103 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K803130 (1981). 19 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 4 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 3 generations backK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
- 2 generations backK103416 Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
- 1 generation backK130318 Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013
- This deviceK161459 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed · 2016
- Descendant · cites it directly · 4 of its ownK171138 Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK172951 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and…Varex Imaging Corporation · 2017
- Descendant · cites it directly · 2 of its ownK183212 Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK190146 Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK193238 Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation · 2019
Most influential descendants
Showing 5 of 5 · See all- K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2017 · cites it directly4descendants
- K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation · 2017 · 2 generations on3descendants
- K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 2018 · cites it directly2descendants
- K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2019 · 2 generations on1descendant
- K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −6 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −5 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −4 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −3 | K093066 | I5 Digital X-Ray Imaging System, Model I5 | Infimed, Inc. | 2010 | — |
| −2 | K103416 | Nexus DRF Digital X-Ray Imaging System | Infimed, Inc. | 2011 | — |
| −1 | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013 | — |
| 0 (this device) | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | Varian Medical Systems, X-Ray Products-Infimed | 2016 | — |
| +1 | K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2017 | — |
| +2 | K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation | 2017 | — |
| +1 | K183212 | Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation | 2018 | — |
| +2 | K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2019 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K992794 | Stingray DR, Model 1Summary page 4…stem Primary Product Code: MQB Primary Predicate Device: 510(k) Number: Product Code: Stingray DR Digital Radiographic System K992794 MQB Reference Predicate Device: 510(k) Number: Product Code: Nexus DRF Digital X-ray Imaging… | 1999 |
| * | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Summary page 4…K992794 MQB Reference Predicate Device: 510(k) Number: Product Code: Nexus DRF Digital X-ray Imaging System K130318 JAA, MQB Device Description: The Varian Nexus DR Digital X-ray Imaging System is a high resolution digital imaging syste… | 2013 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 35 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 19 ancestors have a recall of any class.
- Of its descendants, K171138 (Varex Imaging Corporation, 2017) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K992794.
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. 2016, 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 Varian 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 hardcopy images with a laser…
Read the full statement (130 words)
The Varian 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 hardcopy 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 Varian 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/K161459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161459: Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161459
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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