Cleared Traditional

K212412 - IRIS-XP (FDA 510(k) Clearance)

Class I Radiology device.

K212412 · Medicore Co., Ltd. · Radiology device
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Sep 2021
Decision
41d
Days
Class 1
Risk

K212412 is an FDA 510(k) clearance for the IRIS-XP. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Medicore Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 13, 2021 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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 Medicore Co., Ltd. devices

Submission Details

510(k) Number K212412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2021
Decision Date September 13, 2021
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Gms Consulting
DoGyun Lim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.