510(k) · Cleared
ClearedDR 600 with Tomosynthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa N.V. · IZF System, X-Ray, Tomographic
Cleared on Mar 9, 2020 as substantially equivalent to K183275 (Agfa N.V., 2019) and 1 other predicate after a 104-day review. Its family tree reaches back 9 generations to 1981. 4 later devices descend from it.
- Decided
- Mar 9, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K803130 (1981). 38 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations between
- 3 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 2 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 1 generation backK152639 DR 600Agfa Healthcare N.V. · 2015
- This deviceK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · cites it directly · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK252649 TAP2DNano-X Imaging, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 8 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 6 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 5 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 4 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 3 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 2 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 1 generation backK152639 DR 600Agfa Healthcare N.V. · 2015
- This deviceK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −8 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −7 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −6 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −5 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −4 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −3 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| −2 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| −1 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| 0 (this device) | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +1 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +2 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +3 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| +4 | 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 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IZF? 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 IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 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 |
|---|---|---|---|
| * | K183275 | DR 800 with TomosynthesisSummary page 4…osynthesis which is a tomographic and solid state x- ray system. It is substantially equivalent to both of Agfa’s predicate devices, DR 800 with Tomosynthesis (primary - K183275) and DR 600 (K152639). Primary Predicate Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classificatio… | 2019 |
| * | K152639 | DR 600Summary page 4…tomographic and solid state x- ray system. It is substantially equivalent to both of Agfa’s predicate devices, DR 800 with Tomosynthesis (primary - K183275) and DR 600 (K152639). Primary Predicate Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X… | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222934 | Nanox.ARC | 2023 | 3 |
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 39 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 20 of the 38 ancestors have a recall of any class.
- Of its descendants, K222934 (Nano-X Imaging, Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K183275.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DR 600 system is a General Radiography 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, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire…
Read the full statement (116 words)
The DR 600 system is a General Radiography 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, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Applications can be performed with the patient in the sitting, standing or lying position.
This system is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193262: DR 600 with Tomosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193262
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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