510(k) · Cleared
ClearedDR 600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 11, 2015 as substantially equivalent to K112670 (Agfa Healthcare N.V., 2011) and 1 other predicate after an 87-day review. Its family tree reaches back 8 generations to 1981. 6 later devices descend from it.
- Decided
- Dec 11, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K803130 (1981). 29 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 4 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 3 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 2 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 1 generation backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- This deviceK152639 DR 600Agfa Healthcare N.V. · 2015
- Descendant · cites it directly · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 2 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- Descendant · 5 generations on · 0 of its ownK252649 TAP2DNano-X Imaging, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · cites it directly4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 2 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 3 generations on2descendants
- K250850Nanox.ARC XNano-X Imaging, Ltd. · 2025 · 4 generations on1descendant
- K252649TAP2DNano-X Imaging, Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −7 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −6 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −5 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −4 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −2 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| −1 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| 0 (this device) | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| +1 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +2 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +3 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +4 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| +5 | K252649 | TAP2D | Nano-X Imaging, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112670 | DX-D 600Summary page 4…: MQB III. PREDICATE DEVICES This is a 510(k) for Agfa’s DR 600, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa’s DX-D 600 (K112670) and DR 400 (K141192). These predicates have not been subject to a design-related recall. No reference devices were used in this… | 2011 |
| * | K141192 | DR 400Summary page 4…CATE DEVICES This is a 510(k) for Agfa’s DR 600, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa’s DX-D 600 (K112670) and DR 400 (K141192). These predicates have not been subject to a design-related recall. No reference devices were used in this submission. IV.… | 2014 |
What descends from it? (6)
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 34 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 15 of the 29 ancestors have a recall of any class.
- Of its descendants, K193262 (Agfa N.V., 2020) has gone furthest, with 4 descendants of its own.
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. 2015, 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 DR 600 is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by radiographers. radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spmnal column and extremities), chest, abdomen and other body parts on adults and pediatric patients.
Applications can be performed with the patient in sitting, standing or lying position.
The DR 600 is not intended for use in Mammography applications.
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/K152639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152639: DR 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152639
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