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510(k) K203653

MRI PPG Patient Cable by Ivy Biomedical Systems, Inc. — Product Code LNH

K203653 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "MRI PPG Patient Cable". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ivy Biomedical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
December 15, 2020
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 Ivy Biomedical Systems, Inc.

  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K192852 — MRI ECG Patient Cable (March 28, 2020)
  • K171778 — MR Wireless Gating System, Model WGS-100 (March 14, 2018)
  • K170828 — Cardiac Trigger Monitor (May 17, 2017)
  • K151781 — Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (May 27, 2016)
  • K110987 — CARDIAC TRIGGER MONITOR (July 22, 2011)
  • K091787 — MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (October 9, 2009)
  • K091985 — UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (July 24, 2009)
  • K083854 — CARDIAC TRIGGER, MODEL: CTM300 (February 13, 2009)

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