Cleared Traditional

K012941 - DRYSTAR

K012941 is an FDA 510(k) clearance for DRYSTAR, manufactured by Agfa Corp.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012941 · Agfa Corp. · Radiology device
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Nov 2001
Decision
90d
Days
Class 2
Risk

K012941 is an FDA 510(k) clearance for the DRYSTAR, MODEL 4500M. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Agfa Corp. (Rockville, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Agfa Corp. devices

FDA 510(k) Submission Details - K012941

510(k) Number K012941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date November 29, 2001
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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 - LMC Camera, Multi Format, Radiological

All 55
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K012941.
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