NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)— 510(k) K020300

Name: FDA 510(k) clearance K020300
Creator: U.S. Food and Drug Administration
Published: 2002-04-23

Substantially Equivalent

Syntermed, Inc.

FDA 510(k) clearance K020300 for NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS), Substantially Equivalent on 2002-04-23. 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: 2002-01-29
Decision date: 2002-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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

More clearances from Syntermed, Inc.

view all

K130902 — EMORY CARDIAC TOOLBOX 3.22013-06-14
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

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