BrainInsight— 510(k) K223268

Substantially Equivalent

Hyperfine, Inc.

FDA 510(k) clearance K223268 for BrainInsight, Substantially Equivalent on 2022-12-16. Applicant: Hyperfine, Inc..

Clearance details

Applicant: Hyperfine, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2022-10-24
Decision date: 2022-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilforf, CT, US

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