Cleared Special

K032635 - DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300

K032635 is an FDA 510(k) clearance for DRYSTAR 5300 MEDICAL IMAGE PRINTER, manufactured by Agfa Corp.. The device is a Class 2 Radiology device with product code LMC cleared through the Special 510(k) pathway after a 29-day FDA review.

K032635 · Agfa Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
29d
Days
Class 2
Risk

K032635 is an FDA 510(k) clearance for the DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on September 24, 2003 after a review of 29 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.

FDA 510(k) Submission Details - K032635

510(k) Number K032635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date September 24, 2003
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 90
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