Neurophet SCALE PET— 510(k) K252563

Substantially Equivalent

Neurophet., Inc.

FDA 510(k) clearance K252563 for Neurophet SCALE PET, Substantially Equivalent on 2026-05-15. Applicant: Neurophet., Inc..

Clearance details

Applicant: Neurophet., Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-08-14
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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