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

Name: FDA 510(k) clearance K864519
Creator: U.S. Food and Drug Administration
Published: 1987-02-13

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.. Device class: 2.

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1986-11-17
Decision date: 1987-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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K904901 — L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC1991-03-26
K904902 — SMA 26 TRANSDUCER1991-03-26
K884800 — ACTA GENOS ELECTROCARDIOGRAPH1989-06-22
K862414 — FUJI CR IMAGING PLATE1987-02-26

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.