Cleared Traditional

K031801 - PANTOS, MODELS: PANTOS 16, AND PANTOS DG

K031801 is an FDA 510(k) clearance for PANTOS, manufactured by Blue X Imaging Srl. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K031801 · Blue X Imaging Srl · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
92d
Days
Class 2
Risk

K031801 is an FDA 510(k) clearance for the PANTOS, MODELS: PANTOS 16, AND PANTOS DG. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Blue X Imaging Srl (Wheeling, US). The FDA issued a Cleared decision on September 11, 2003 after a review of 92 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K031801

510(k) Number K031801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2003
Decision Date September 11, 2003
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

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 206
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K031801 · PANTOS, MODELS: PANTOS 16, AND PANTOS DG
Download PDF FDA Summary Blue X Imaging Srl