CARDIAC SCANNER AND PROCESSING SYSTEM— 510(k) K110507

Name: FDA 510(k) clearance K110507
Creator: U.S. Food and Drug Administration
Published: 2011-07-13

Substantially Equivalent

Spectrum Dynamics (Israel) , Ltd.

FDA 510(k) clearance K110507 for CARDIAC SCANNER AND PROCESSING SYSTEM, Substantially Equivalent on 2011-07-13. Applicant: Spectrum Dynamics (Israel) , Ltd.. Device class: 2.

Clearance details

Applicant: Spectrum Dynamics (Israel) , Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2011-02-22
Decision date: 2011-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zichron Yaacov, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

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

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