Cleared Traditional

K934645 - RADWORKS

K934645 is an FDA 510(k) clearance for RADWORKS, manufactured by Radworks Corp.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K934645 · Radworks Corp. · Radiology device
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Aug 1994
Decision
330d
Days
Class 2
Risk

K934645 is an FDA 510(k) clearance for the RADWORKS. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Radworks Corp. (San Antonio, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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. Elevated predicate reliance profile. 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 Radworks Corp. devices

FDA 510(k) Submission Details - K934645

510(k) Number K934645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date August 17, 1994
Days to Decision 330 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 107d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 15
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K934645.
ATLANTIS
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TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
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TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
PORTARAY
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