Cleared Traditional

K193218 - Innovision Audio

K193218 is an FDA 510(k) clearance for Innovision Audio, manufactured by Innovere Medical, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K193218 · Innovere Medical, Inc. · Radiology device
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Apr 2020
Decision
138d
Days
Class 2
Risk

K193218 is an FDA 510(k) clearance for the Innovision Audio. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Innovere Medical, Inc. (Markham, CA). The FDA issued a Cleared decision on April 7, 2020 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovere Medical, Inc. devices

FDA 510(k) Submission Details - K193218

510(k) Number K193218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2019
Decision Date April 07, 2020
Days to Decision 138 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 107d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 871
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K193218.
uMR 570
K200024 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K193215 · Philips Medical Systems Nederland B.V. · Apr 2020
SIGNA Premier
K193282 · Ge Healthcare (Ge Medical Systems, LLC) · Apr 2020
MRI ECG Patient Cable
K192852 · Ivy Biomedical Systems, Inc. · Mar 2020
uMR Omega
K193200 · Shanghai United Imaging Healthcare Co., Ltd. · Mar 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
K192924 · Siemens Medical Solutions USA, Inc. · Mar 2020