Emory Cardiac Toolbox 4.3— 510(k) K223422

Substantially Equivalent

Syntermed

FDA 510(k) clearance K223422 for Emory Cardiac Toolbox 4.3, Substantially Equivalent on 2023-03-30. Applicant: Syntermed. Device class: 2.

Clearance details

Applicant: Syntermed
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2022-11-14
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
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 Syntermed

K180077 — NeuroQ 3.82018-08-16

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