SpectraWAVE Imaging System— 510(k) K221257

Substantially Equivalent

Spectrawave, Inc.

FDA 510(k) clearance K221257 for SpectraWAVE Imaging System, Substantially Equivalent on 2023-02-28. Applicant: Spectrawave, Inc..

Clearance details

Applicant: Spectrawave, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2022-05-02
Decision date: 2023-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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