510(k) · Cleared
ClearedNanox.ARC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nano-X Imaging, Ltd. · IZF System, X-Ray, Tomographic
Cleared on Apr 28, 2023 as substantially equivalent to K193262 (Agfa N.V., 2020) after a 214-day review. Its family tree reaches back 10 generations to 1981. 3 later devices descend from it.
- Decided
- Apr 28, 2023
- Review
- 214 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K803130 (1981). 39 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations between
- 3 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 2 generations backK152639 DR 600Agfa Healthcare N.V. · 2015
- 1 generation backK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- This deviceK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252649 TAP2DNano-X Imaging, Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 9 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 7 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 6 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 5 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 4 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 3 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 2 generations backK152639 DR 600Agfa Healthcare N.V. · 2015
- 1 generation backK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- This deviceK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −9 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −8 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −7 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −6 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −4 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| −3 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| −2 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| −1 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| 0 (this device) | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +1 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +2 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K193262 | DR 600 with TomosynthesisSummary page 6…AGFA NV. Predicate Trade Name: DR 600 with Tomosynthesis Predicate Classification Code: IZF and MQB Predicate 510(k): K193262 Reference Manufacturer: AGFA NV. Reference Trade Name: DR 800 with Tomosynthesis Reference… | 2020 |
| † | K183275 | DR 800 with Tomosynthesis | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242395 | Nanox.ARC | 2024 | 2 |
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 42 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 20 of the 39 ancestors have a recall of any class.
- Of its descendants, K242395 (Nano-X Imaging, Ltd., 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesis is used to synthesize…
Read the full statement (106 words)
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, angiographic, cardiac, pulmonary, intra-abdominal, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222934: Nanox.ARC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222934
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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