TAP2D— 510(k) K252649
Substantially EquivalentNano-X Imaging , Ltd.
FDA 510(k) clearance K252649 for TAP2D, Substantially Equivalent on 2026-02-02. Applicant: Nano-X Imaging , Ltd.. Device class: 2.
Summary
Nano-X Imaging filed a device named only TAP2D under product code IZF, tomographic x-ray system. The record doesn't describe it beyond that name and code name.
Class II, 21 CFR 892.1740. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nano-X Imaging filed from Petah Tikva, Israel. The decision came 165 calendar days after FDA received it (August 21, 2025 to February 2, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Nano-X Imaging , Ltd.
- Product code
- Product code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Petah Tikva, IL
Recent devices under product code IZF
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