K254001

Substantially Equivalent

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Applicant: Spectrum Dynamics Medical, Ltd.
Product code: KPS
Advisory panel: Radiology
Date received: 2025-12-15
Decision date: 2026-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

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Data sourced from openFDA. This site is unofficial and independent of the FDA.