FDA 510(k) clearance · back to tracker

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM

Philips Medical Systems North America, Inc. cleared K885327 on 1989-05-11, decision: substantially equivalent

K-number

K885327

Sponsor

Philips Medical Systems North America, Inc.

Device

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1989-05-11

Product code

LMB

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2010

Official FDA record

Open K885327on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K885327 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.