Nano-X Imaging Ltd (Nanox), an innovative medical imaging technology company, announced that its single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and Drug Administration.

April 2, 2021 — Nano-X Imaging Ltd. (Nanox), an innovative medical imaging technology company, announced that its single-source Nanox.ARC digital X-ray technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

“Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital X-ray is a significant step forward along our U.S. regulatory pathway,” stated Ran Poliakine, chairman and chief executive officer of Nanox. “We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024.”

“We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited or no meaningful access to imaging or the preventative screening that it offers,” Poliakine concluded.

The company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the company’s commercial imaging system that it expects to deploy broadly across the globe.

The system is unique in that it uses cold-cathod X-ray technology. This greatly reduces the amount of heat generated and the amount of energy consumed, allowing for much lighter weight and less expensive X-ray systems. 

Read more about this technology in the article Cold Cathode X-ray Technology Demonstrated at RSNA 2020.

For more information: www.nanox.vision

 

Carestream Showing New Mobile X-ray System With Carbon Nanotube Technology at AHRA

 

Related Content

News | Digital Radiography (DR)

October 21, 2021 — Carestream Health will demonstrate advanced capabilities in digital radiography (DR) rooms at the ...

Time October 21, 2021
arrow
News | Artificial Intelligence

October 19, 2021 — South Korean artificial intelligence (AI) developer, VUNO Inc., announced that the company closed a ...

Time October 19, 2021
arrow
Videos | Coronavirus (COVID-19)

An example of popliteal artery thrombosis formation caused by COVID-19 (SARS-CoV-2). Coronavirus often caused thrombus ...

Time October 19, 2021
arrow
News | Radiographic Fluoroscopy (RF)

October 18, 2021 — Long Island Jewish Valley Stream of Valley Stream, N.Y., recently became the first healthcare ...

Time October 18, 2021
arrow
News | Ultrasound Imaging

October 15, 2021 — NeuroLogica Corp., the U.S. healthcare subsidiary of Samsung, introduces the V8; a high-end ...

Time October 15, 2021
arrow
News | Computed Tomography (CT)

October 14, 2021 — Cardiac computed tomography angiography (CTA) derived left atrium emptying fraction (LAEF) improves ...

Time October 14, 2021
arrow
News | Radiology Business

October 14, 2021 — Intelerad Medical Systems, a global leader in medical image management solutions, today announced its ...

Time October 14, 2021
arrow
News | Artificial Intelligence

October 11, 2021 — The Icahn School of Medicine at Mount Sinai has launched a new department dedicated to advancing ...

Time October 11, 2021
arrow
News | Radiology Business

October 8, 2021 — Commonwealth Radiology Associates (CRA) is the largest private practice radiology group in ...

Time October 08, 2021
arrow
News | Enterprise Imaging

October 8, 2021 — HealthLevel, Inc., innovator of Foundations, a business operations analytics platform for healthcare ...

Time October 08, 2021
arrow
Subscribe Now