Cleared Traditional

K921219 - PHILIPS DCI-SX

K921219 is the FDA 510(k) clearance for PHILIPS DCI-SX by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 777-day FDA review.

K921219 · Philips Medical Systems, Inc. · Radiology device
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Apr 1994
Decision
777d
Days
Class 2
Risk

K921219 is an FDA 510(k) clearance for the PHILIPS DCI-SX. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on April 29, 1994 after a review of 777 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K921219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date April 29, 1994
Days to Decision 777 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
670d slower than avg
Panel avg: 107d · This submission: 777d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 241
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K921219.
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CSP
K912448 · Fischer Imaging Corp. · Aug 1991