Cleared Traditional

K221785 - TCL3 Motion Tracking System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221785 · Tracinnovations A/S · Radiology device
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Aug 2022
Decision
69d
Days
Class 2
Risk

K221785 is an FDA 510(k) clearance for the TCL3 Motion Tracking System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Tracinnovations A/S (Ballerup, DK). The FDA issued a Cleared decision on August 29, 2022 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tracinnovations A/S devices

Submission Details

510(k) Number K221785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2022
Decision Date August 29, 2022
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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