510(k) K253192
- Device
- DeepXray Spina
- Applicant
- Alpha Intelligence Manifolds, Inc.
- 510(k) number
- K253192
- Product code
- SAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-10
- Date received
- 2025-09-26
- Regulation
- 892.1171
- Classification name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Qingzong TSENG
- Address
- 2f, # 170, Zhonghe Rd., Zhonghe Dist. New Taipei City TW 235068 235068
FDA Registration Numbers#
- 3041277558
- 3033583855