Nanox.ARC
FDA 510(k) K222934 · Nano-X Imaging , Ltd.
510(k) numberK222934
Submission
- Device name
- Nanox.ARC
- Applicant
- Nano-X Imaging , Ltd.
Neve Ilan, IL - Received
- September 26, 2022
- Decision date
- April 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252649 | TAP2DIZF · Traditional | Nano-X Imaging , Ltd. | 02/02/2026SE |
| K252133 | Adaptix Ortho350IZF · Traditional | Adaptix Limited | 11/06/2025SE |
| K250850 | Nanox.ARC XIZF · Traditional | Nano-X Imaging , Ltd. | 04/16/2025SE |
| K242395 | Nanox.ARCIZF · Traditional | Nano-X Imaging , Ltd. | 12/04/2024SE |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemIZF · Traditional | Pausch Medical GmbH | 01/26/2023SE |
| K213081 | CLISIS SYSTEMS, Discovery RF180IZF · Traditional | General Medical Merate S.P.A | 10/26/2021SE |
| K193262 | DR 600 with TomosynthesisIZF · Traditional | Agfa N.V. | 03/09/2020SE |
| K183275 | DR 800 with TomosynthesisIZF · Traditional | Agfa N.V. | 02/01/2019SE |
| K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)IZF · Traditional | Ge Medical Systems, LLC | 11/18/2013SE |
| K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemIZF · Traditional | Fujifilm Medical System U.S.A., Inc. | 11/20/2012SE |
More from Fujifilm Medical System U.S.A., Inc.
Questions and answers
When was Nanox.ARC cleared by the FDA?
Nanox.ARC (K222934) received a 510(k) decision of Substantially Equivalent on April 28, 2023, 214 days after the submission was received.
What is the product code of K222934?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.