CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS— 510(k) K070542

Name: FDA 510(k) clearance K070542
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K070542 for CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS, Substantially Equivalent on 2007-03-23. Applicant: Digirad Corp.. Device class: 2.

Clearance details

Applicant: Digirad Corp.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2007-02-26
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, 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 Digirad Corp.

view all

K123408 — ERGO IMAGING SYSTEM2013-01-15
K100838 — ERGO IMAGING SYSTEM2010-04-23
K083649 — CARDIUS 3 X-ACT2009-03-09
K082904 — STASYS MOTION CORRECTION SOFTWARE2008-12-17
K082368 — CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM2008-09-12

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