Cleared Special

K072680 - DRYSTAR AXYS

K072680 is an FDA 510(k) clearance for DRYSTAR AXYS, manufactured by Agfa Healthcare Corporation. The device is a Class 2 Radiology device with product code LMC cleared through the Special 510(k) pathway after a 31-day FDA review.

K072680 · Agfa Healthcare Corporation · Radiology device
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Oct 2007
Decision
31d
Days
Class 2
Risk

K072680 is an FDA 510(k) clearance for the DRYSTAR AXYS, MODEL EYZ4E. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Agfa Healthcare Corporation (Greenville, US). The FDA issued a Cleared decision on October 25, 2007 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Agfa Healthcare Corporation devices

FDA 510(k) Submission Details - K072680

510(k) Number K072680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date October 25, 2007
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 38
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