Cleared Traditional

K885327 - PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K885327 · Philips Medical Systems North America, Inc. · Radiology device
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May 1989
Decision
134d
Days
Class 1
Risk

K885327 is an FDA 510(k) clearance for the PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems North America, Inc. devices

Submission Details

510(k) Number K885327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date May 11, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.