HyperVue Imaging System - Integrated— 510(k) K253101

Substantially Equivalent

Spectrawave, Inc.

FDA 510(k) clearance K253101 for HyperVue Imaging System - Integrated, Substantially Equivalent on 2025-12-15. Applicant: Spectrawave, Inc..

Clearance details

Applicant: Spectrawave, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2025-09-24
Decision date: 2025-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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