Neurophet SCALE PET— 510(k) K252563
Substantially EquivalentNeurophet., Inc.
FDA 510(k) clearance K252563 for Neurophet SCALE PET, Substantially Equivalent on 2026-05-15. Applicant: Neurophet., Inc.. Device class: 2.
Clearance details
- Applicant
- Neurophet., Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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