Cleared Traditional

MRI PPG Patient Cable

K203653 · Ivy Biomedical Systems, Inc. · Radiology
Mar 2021
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K203653 is an FDA 510(k) clearance for the MRI PPG Patient Cable, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 2, 2021, 77 days after receiving the submission on December 15, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K203653 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2020
Decision Date March 02, 2021
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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