Cleared Traditional

K945580 - DSP OPTION

K945580 is the FDA 510(k) clearance for DSP OPTION by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code IZJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K945580 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
77d
Days
Class 2
Risk

K945580 is an FDA 510(k) clearance for the DSP OPTION. Classified as Camera, X-ray, Fluorographic, Cine Or Spot (product code IZJ), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1620 - 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K945580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date January 30, 1995
Days to Decision 77 days
Submission Type Traditional
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
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZJ Camera, X-ray, Fluorographic, Cine Or Spot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1620
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 - IZJ Camera, X-ray, Fluorographic, Cine Or Spot

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