PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)— 510(k) K864519

Substantially Equivalent

Parexel Intl. Corp.

FDA 510(k) clearance K864519 for PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR), Substantially Equivalent on 1987-02-13. Applicant: Parexel Intl. Corp..

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1986-11-17
Decision date: 1987-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.