TruSPECT Processing Station— 510(k) K253532

Substantially Equivalent

Spectrum Dynamics Medical, Ltd.

FDA 510(k) clearance K253532 for TruSPECT Processing Station, Substantially Equivalent on 2025-12-30. Applicant: Spectrum Dynamics Medical, Ltd..

Clearance details

Applicant: Spectrum Dynamics Medical, Ltd.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-11-13
Decision date: 2025-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

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