BIOGRAPH One— 510(k) K253023
Substantially EquivalentSiemens Healthineers AG
FDA 510(k) clearance K253023 for BIOGRAPH One, Substantially Equivalent on 2026-01-15. Applicant: Siemens Healthineers AG. Device class: 2.
Clearance details
- Applicant
- Siemens Healthineers AG
- Product code
- Code OUO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Forchheim, DE
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