QED DIODE DETECTORS, MODELS 1112-1116— 510(k) K011466

Name: FDA 510(k) clearance K011466
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Sun Nuclear Corp.

FDA 510(k) clearance K011466 for QED DIODE DETECTORS, MODELS 1112-1116, Substantially Equivalent on 2001-06-06. Applicant: Sun Nuclear Corp.. Device class: 2.

Clearance details

Applicant: Sun Nuclear Corp.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2001-05-14
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Melbourne, FL, 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 Sun Nuclear Corp.

view all

K112981 — SUN 125C IONIZATION CHAMBER2012-01-25
K101992 — 3D SCANNER, MODEL 12302010-10-01
K092019 — MODEL 1014 PC ELECTROMETER2009-09-15
K063021 — PROFILER 22006-11-22
K051921 — THE EDGE DETECTOR, MODEL 11182005-07-27

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.