cNeuro cPET— 510(k) K231576

Substantially Equivalent

Combinostics OY

FDA 510(k) clearance K231576 for cNeuro cPET, Substantially Equivalent on 2023-09-14. Applicant: Combinostics OY. Device class: 2.

Clearance details

Applicant: Combinostics OY
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2023-05-31
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

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K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Combinostics OY

K233908 — cNeuro cDAT2024-07-01
K171328 — cNeuro cMRI2018-01-08

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