Cleared Traditional

K010275 - DRYSTAR 4500 PRINTER, MODEL 4500

K010275 is an FDA 510(k) clearance for DRYSTAR 4500 PRINTER, manufactured by Agfa Medical Imaging. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K010275 · Agfa Medical Imaging · Radiology device
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Apr 2001
Decision
87d
Days
Class 2
Risk

K010275 is an FDA 510(k) clearance for the DRYSTAR 4500 PRINTER, MODEL 4500. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Agfa Medical Imaging (Rockville, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Agfa Medical Imaging devices

FDA 510(k) Submission Details - K010275

510(k) Number K010275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2001
Decision Date April 27, 2001
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 69
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K010275.
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K991282 · Seiko Instruments USA, Inc. · Jun 1999