EMORY CARDIAC TOOLBOX 3.2— 510(k) K130902

Substantially Equivalent

Syntermed, Inc.

FDA 510(k) clearance K130902 for EMORY CARDIAC TOOLBOX 3.2, Substantially Equivalent on 2013-06-14. Applicant: Syntermed, Inc.. Device class: 2.

Clearance details

Applicant: Syntermed, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2013-04-01
Decision date: 2013-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
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, Inc.

K130451 — NEUROQ 3.62013-05-17
K123646 — EMORY CARDIAC TOOLBOX 4.02013-02-22
K072307 — QUANTITATIVE NEUROQ 3.02008-03-14
K071503 — SYSTEM, TOMOGRAPHY, COMPUTED EMISSION2007-07-26
K070089 — SYNTERMED LIVE2007-03-02

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