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510(k) K232981

Synq Software Version 1.3 by Synaptive Medical, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
September 21, 2023
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 Synaptive Medical, Inc.

  • K231986 — Modus IR (March 25, 2024)
  • K200327 — Evry (April 29, 2020)
  • K183325 — Modus Nav (July 14, 2019)
  • K180394 — BrightMatter Plan 1.6.0 (March 9, 2018)
  • K160523 — BrightMatter Guide with BrightMatter Pointer (June 24, 2016)
  • K153281 — BrightMatter Guide with Surface Trace Registration (March 30, 2016)
  • K153284 — Synaptive ImageDrive Pro (March 29, 2016)
  • K142024 — BRIGHTMATTER NAVIGATION SYSTEM (April 2, 2015)
  • K140337 — BRIGHTMATTER PLANNING SOFTWARE (June 2, 2014)

Other clearances for product code LNH

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  • 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)