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 Dec 4, 2024 as substantially equivalent to K222934 (Nano-X Imaging, Ltd., 2023) after a 113-day review. Its family tree reaches back 11 generations to 1981. 2 later devices descend from it.
- Decided
- Dec 4, 2024
- Review
- 113 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K803130 (1981). 40 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations between
- 3 generations backK152639 DR 600Agfa Healthcare N.V. · 2015
- 2 generations backK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- 1 generation backK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- This deviceK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252649 TAP2DNano-X Imaging, Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 10 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 8 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 7 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 6 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 5 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 4 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 3 generations backK152639 DR 600Agfa Healthcare N.V. · 2015
- 2 generations backK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- 1 generation backK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- This deviceK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −10 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −9 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −8 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −7 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −6 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −5 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| −4 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| −3 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| −2 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| −1 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| 0 (this device) | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +1 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K222934 | Nanox.ARCSummary page 6…21 CFR 807.92(a)(5) Device Intended Use, to produce tomographic images, remains the same as cleared under K222934. The Indications for Use have been expanded from musculoskeletal (MSK) imaging to general use including pulmonary, intra-abdomina… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250850 | Nanox.ARC X | 2025 | 1 |
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 43 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 20 of the 40 ancestors have a recall of any class.
- Of its descendants, K250850 (Nano-X Imaging, Ltd., 2025) has gone furthest, with 1 descendant 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. 2024, 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 for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, 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…
Read the full statement (112 words)
Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use
including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus
indications, 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, intra-cranial, interventional, or
fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
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/K242395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242395: Nanox.ARC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242395
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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