Cleared Traditional

K122806 - IMAGE WORKS PANOURA (FDA 510(k) Clearance)

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

K122806 · Mic International · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
176d
Days
Class 2
Risk

K122806 is an FDA 510(k) clearance for the IMAGE WORKS PANOURA. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Mic International (Tokyo, JP). The FDA issued a Cleared decision on March 8, 2013 after a review of 176 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.

View all Mic International devices

Submission Details

510(k) Number K122806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2012
Decision Date March 08, 2013
Days to Decision 176 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 107d · This submission: 176d
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 205
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K122806.
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024