Nanox.ARC
FDA 510(k) clearance K222934 · decided 2023-04-28
Clearance details
- K-number
- K222934
- Device name
- Nanox.ARC
- Applicant
- Nano-X Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-26
- Decision date
- 2023-04-28
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Neve Ilan, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TAP2D (K252649) | Nano-X Imaging , Ltd. | 2026-02-02 |
| Adaptix Ortho350 (K252133) | Adaptix Limited | 2025-11-06 |
| Nanox.ARC X (K250850) | Nano-X Imaging , Ltd. | 2025-04-16 |
| Nanox.ARC (K242395) | Nano-X Imaging , Ltd. | 2024-12-04 |
| Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949) | Pausch Medical GmbH | 2023-01-26 |
| CLISIS SYSTEMS, Discovery RF180 (K213081) | General Medical Merate S.P.A | 2021-10-26 |
| DR 600 with Tomosynthesis (K193262) | Agfa N.V. | 2020-03-09 |
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |
| DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261) | Ge Medical Systems, LLC | 2013-11-18 |
| FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499) | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (K013620) | Medstone Intl., Inc. | 2002-01-22 |
| PROGNOST ES, MODEL 0302 0000 (K011290) | Xmar Corp. | 2001-05-30 |
Recalls involving this device
No recalls on record reference this clearance.