Cleared Traditional

K885327 - PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM

K885327 is an FDA 510(k) clearance for PHILIPS DIGITAL CARDIAC IMAGING (DCI) S..., manufactured by Philips Medical Systems North America, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

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

FDA 510(k) Submission Details - K885327

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

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.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 33
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