GYREX 2T-SGR— 510(k) K935549

Name: FDA 510(k) clearance K935549
Creator: U.S. Food and Drug Administration
Published: 1994-08-24

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K935549 for GYREX 2T-SGR, Substantially Equivalent on 1994-08-24. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1993-11-17
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

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

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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