NinesAI— 510(k) K193351

Substantially Equivalent

Nines, 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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