Cleared Traditional

K933632 - MEDSCAN 12

K933632 is an FDA 510(k) clearance for MEDSCAN 12, manufactured by Vidar Systems Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K933632 · Vidar Systems Corp. · Radiology device
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Dec 1993
Decision
139d
Days
Class 2
Risk

K933632 is an FDA 510(k) clearance for the MEDSCAN 12. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Vidar Systems Corp. (Herndon, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Vidar Systems Corp. devices

FDA 510(k) Submission Details - K933632

510(k) Number K933632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date December 13, 1993
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

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