Cleared Abbreviated

K033577 - UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K033577 · Medlink Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
491d
Days
Class 2
Risk

K033577 is an FDA 510(k) clearance for the UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Medlink Imaging (Deer Field, US). The FDA issued a Cleared decision on March 18, 2005 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Medlink Imaging devices

Submission Details

510(k) Number K033577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date March 18, 2005
Days to Decision 491 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
384d slower than avg
Panel avg: 107d · This submission: 491d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

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