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510(k) K011466

QED DIODE DETECTORS, MODELS 1112-1116 by Sun Nuclear Corp. — Product Code LNH

K011466 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "QED DIODE DETECTORS, MODELS 1112-1116". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
May 14, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Sun Nuclear Corp.

  • K112981 — SUN 125C IONIZATION CHAMBER (January 25, 2012)
  • K101992 — 3D SCANNER, MODEL 1230 (October 1, 2010)
  • K092019 — MODEL 1014 PC ELECTROMETER (September 15, 2009)
  • K063021 — PROFILER 2 (November 22, 2006)
  • K051921 — THE EDGE DETECTOR, MODEL 1118 (July 27, 2005)
  • K013689 — RE-ENTRANT CHAMBER (July 2, 2002)
  • K021463 — MODEL 1133 IVD PC VERSION (June 6, 2002)
  • K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133 (July 26, 2001)
  • K010449 — IVD (IN VIVO DOSIMETER), MODEL 1131 (May 4, 2001)
  • K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (October 23, 2000)

Other clearances for product code LNH

  • K260113 — uMR Astra (May 22, 2026)
  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260746 — S-scan Open (100001800) (March 27, 2026)
  • K251937 — nordicAudio (1.0) (March 20, 2026)
  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)

FDA data resources