NinesAI— 510(k) K193351
Substantially EquivalentNines, Inc.
FDA 510(k) clearance K193351 for NinesAI, Substantially Equivalent on 2020-04-21. Applicant: Nines, Inc.. Device class: 2.
Clearance details
- Applicant
- Nines, Inc.
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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