Annalise Enterprise— 510(k) K250831
Substantially EquivalentAnnalise-Ai
FDA 510(k) clearance K250831 for Annalise Enterprise, Substantially Equivalent on 2025-04-23. Applicant: Annalise-Ai. Device class: 2.
Clearance details
- Applicant
- Annalise-Ai
- Product code
- Code QFM
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sydney, AU
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