Cleared Traditional

K180671 - MINE (FDA 510(k) Clearance)

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

K180671 · Rht Co., Ltd. · Radiology device
Jun 2019
Decision
448d
Days
Class 2
Risk

K180671 is an FDA 510(k) clearance for the MINE. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).

Submitted by Rht Co., Ltd. (Gwangju, KR). The FDA issued a Cleared decision on June 5, 2019, 448 days after receiving the submission on March 14, 2018.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K180671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date June 05, 2019
Days to Decision 448 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 127d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

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