510(k) · Cleared
ClearedTAP2D
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 Feb 2, 2026 as substantially equivalent to K250850 (Nano-X Imaging, Ltd., 2025) after a 165-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Feb 2, 2026
- Review
- 165 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K803130 (1981). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 9 generations between
- 3 generations backK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- 2 generations backK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- 1 generation backK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- This deviceK252649 TAP2DNano-X Imaging, Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 12 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 10 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 9 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 8 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 7 generations backK103050 DX-D 300Agfa Healthcare N.V. · 2010
- 6 generations backK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- 5 generations backK152639 DR 600Agfa Healthcare N.V. · 2015
- 4 generations backK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- 3 generations backK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- 2 generations backK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- 1 generation backK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- This deviceK252649 TAP2DNano-X Imaging, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −12 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −11 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −10 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −9 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −8 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −7 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| −6 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| −5 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| −4 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| −3 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| −2 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| −1 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250850 | Nanox.ARC XSummary page 5…mmon Name: System, X-Ray, Tomographic Regulation Number: 21 CFR 892.1740 Product Code(s): IZF, MQB, LLZ III. PREDICATE DEVICE Predicate #: K250850 Predicate Trade Name: Nanox.ARC X Product Code: IZF, MQB IV. REFERENCE DEVICE #1 Predicate #: K100… | 2025 |
| † | K100372 | Safect Model Ver 1.0 | 2010 |
| † | K160852 | Zia | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 20 of the 42 ancestors have a recall of any class.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
TAP2D is a cloud-based software-module accessory intended exclusively for use with the Nanox.ARC X and Nanox.ARC systems, consistent with their cleared indications for use.
TAP2D is intended to provide a supplemental processed and enhanced 2D view image in DICOM format of a single 2D projection extracted from the acquired DTS study.
TAP2D is specifically indicated for assisting radiologists when evaluating diagnostic tomosynthesis studies and reaching their own diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252649: TAP2D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252649
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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