Cleared Traditional

K052251 - DRYSTAR MODEL 5500

K052251 is an FDA 510(k) clearance for DRYSTAR MODEL 5500, manufactured by Agfa Corporation. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K052251 · Agfa Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
13d
Days
Class 2
Risk

K052251 is an FDA 510(k) clearance for the DRYSTAR MODEL 5500. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Agfa Corporation (Greenville, US). The FDA issued a Cleared decision on August 31, 2005 after a review of 13 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.

FDA 510(k) Submission Details - K052251

510(k) Number K052251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2005
Decision Date August 31, 2005
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 120
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K052251.
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K052251 · DRYSTAR MODEL 5500
Download PDF FDA Summary Agfa Corporation