Clearance Summary
HnX-P1, HnX-PB received FDA 510(k) clearance under submission number K251223, sponsored by H&abyz Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-08-04.
- Submission: K251223
- Applicant / Sponsor: H&abyz Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2025-08-04
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.