BBX-PET Scanner— 510(k) K210450

Substantially Equivalent

Prescient Imaging, LLC

FDA 510(k) clearance K210450 for BBX-PET Scanner, Substantially Equivalent on 2021-03-17. Applicant: Prescient Imaging, LLC.

Clearance details

Applicant: Prescient Imaging, LLC
Product code: Code KPS
Advisory panel: Radiology
Date received: 2021-02-16
Decision date: 2021-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

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