X1-FFR— 510(k) K251355

Substantially Equivalent

Spectrawave, Inc.

FDA 510(k) clearance K251355 for X1-FFR, Substantially Equivalent on 2025-10-17. Applicant: Spectrawave, Inc..

Clearance details

Applicant: Spectrawave, Inc.
Product code: Code QHA
Advisory panel: Radiology
Date received: 2025-04-30
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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