Home / 510(k) Clearances / K082100

510(k) K082100

ALLTECH ECHOSTAR 1.5 T MR SYSTEM by Alltech Medical Systems America, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2008
Date Received
July 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Alltech Medical Systems America, Inc.

  • K163192 — Comfort EC710 (April 10, 2017)
  • K141945 — ECHOSTAR COMFORT 1.5T MRI (February 3, 2015)
  • K113511 — ECHOSTAR SPICA 1.5T MR SYSTEM (May 2, 2012)

Other clearances for product code LNH

  • 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)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)