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510(k) K884816

ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY by Diasonics, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1989
Date Received
November 17, 1988
Clearance Type
Traditional
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 Diasonics, Inc.

  • K962662 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM (January 2, 1997)
  • K924079 — CFM-800 COLOR FLOW MAPPING SYSTEM (September 28, 1993)
  • K911435 — CPA/3.5 MHZ PROBE (September 11, 1992)
  • K905200 — SACA, 3.5 MHZ PROBE (April 2, 1992)
  • K903562 — CW DOPPLER 2.25 MHZ PROBE (March 2, 1992)
  • K903984 — CW DOPPLER/4.5 MHZ (June 14, 1991)
  • K896637 — ACCESS(TM), SOFTWARE RELEASE 4.11P (January 22, 1990)
  • K893518 — MT/S SOFTWARE RELEASE 5.0. (October 27, 1989)
  • K894290 — ACCESS TM (September 7, 1989)
  • K893881 — ACCESS TM (June 23, 1989)

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  • 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)