Nanox Receives FDA 510(k) Clearance for TAP2D New Image Enhancement Capability for Nanox.ARC and Nanox.ARC X Systems
NANO-X IMAGING LTD - Ordinary Shares (NNOX)
Company Research
Source: GlobeNewswire
This clearance enables the next phase of development aimed ultimately at removing the adjunct use in the US The newly cleared capability provides radiologists with a 2D image generated directly from the tomosynthesis scan, enabling both 3D and 2D views from a single scan, without exposing the patient to any additional radiation PETACH TIKVA, Israel – February 3 – NANO-X IMAGING LTD (“Nanox” or the “Company”) today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for TAP2D, a new cloud enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. This clearance marks an important step in Nanox's regulatory strategy to position its tomosynthesis systems as primary diagnostic solutions and advances the Company’s commitment to increased access to innovative medical imaging solutions. The newly cleared enhancement capability provides radiologists with an additional, clear 2D view, generated from th
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News
- Nanox Receives FDA 510(k) Clearance for TAP2D New Image Enhancement Capability for Nanox.ARC and Nanox.ARC X Systems [Yahoo! Finance]Yahoo! Finance
- AI Medical Imaging Revolution: Software-Native Tech Disrupts $45B MarketPR Newswire
- Nanox Expands in Europe with New Nanox.ARC Distribution Engagement in Serbia, Montenegro, and Bosnia and HerzegovinaGlobeNewswire
- Nano-X Imaging Remains Underwhelming Despite Recent Wins [Seeking Alpha]Seeking Alpha
- Nanox Engages with Althea France to Accelerate European Commercialization of Nanox.ARC SystemGlobeNewswire
NNOX
Sec Filings
- 2/3/26 - Form 6-K
- 12/29/25 - Form 6-K
- 12/22/25 - Form 6-K
- NNOX's page on the SEC website