TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA— 510(k) K952674

Name: FDA 510(k) clearance K952674
Creator: U.S. Food and Drug Administration
Published: 1995-09-26

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K952674 for TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA, Substantially Equivalent on 1995-09-26. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1995-06-12
Decision date: 1995-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, 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 Elscint, Inc.

view all

K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY1998-12-11
K982060 — VOLUMAX CT IMAGING SYSTEM1998-09-02
K974344 — CT SCOPE1998-06-03
K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP1998-04-02
K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-01021998-03-04

Recalls naming K952674

K-number listed on FDA's recall record

Z-0290-2026 — Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass II·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·20250912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952674.

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