Cleared Traditional

K182198 - Panoura X-ERA PF/NF/MF (FDA 510(k) Clearance)

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

K182198 · The Yoshida Dental Mfg. Co., Ltd. · Radiology device
Jan 2019
Decision
170d
Days
Class 2
Risk

K182198 is an FDA 510(k) clearance for the Panoura X-ERA PF/NF/MF. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Sumida-Ku, JP). The FDA issued a Cleared decision on January 31, 2019 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

Submission Details

510(k) Number K182198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date January 31, 2019
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 128d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 11
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