Cleared Traditional

K031448 - RSV (RADIOLOGY SYSTEM VISIODENT

K031448 is an FDA 510(k) clearance for RSV (RADIOLOGY SYSTEM VISIODENT, manufactured by Visiodent SA. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K031448 · Visiodent SA · Radiology device
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Jul 2003
Decision
85d
Days
Class 2
Risk

K031448 is an FDA 510(k) clearance for the RSV (RADIOLOGY SYSTEM VISIODENT. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Visiodent SA (Ormond Beach, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 85 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 - K031448

510(k) Number K031448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date July 31, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

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

All 189
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K031448 · RSV (RADIOLOGY SYSTEM VISIODENT
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