Neurophet AQUA (V3.1)— 510(k) K242215

Substantially Equivalent

Neurophet., Inc.

FDA 510(k) clearance K242215 for Neurophet AQUA (V3.1), Substantially Equivalent on 2024-10-25. 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: 2024-07-29
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Neurophet., Inc.

K252563 — Neurophet SCALE PET2026-05-15
K261273 — Neurophet AQUA2026-05-15
K252496 — Neurophet AQUA AD Plus2026-01-29
K220437 — Neurophet AQUA2023-05-10
K221405 — Neurophet SCALE PET2022-08-05

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