Cleared Traditional

K031291 - CDR PANX, MODEL 4792

K031291 is an FDA 510(k) clearance for CDR PANX, manufactured by Schick Technologies, Inc.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K031291 · Schick Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
12d
Days
Class 2
Risk

K031291 is an FDA 510(k) clearance for the CDR PANX, MODEL 4792. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Long Island City, US). The FDA issued a Cleared decision on May 5, 2003 after a review of 12 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031291

510(k) Number K031291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date May 05, 2003
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services

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.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 206
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K031291.
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MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
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K031291 · CDR PANX, MODEL 4792
Download PDF FDA Summary Schick Technologies, …