PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)

System, Image Processing, Radiological

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Philips Computed Radiography System (pcr).

Pre-market Notification Details

Device IDK864519
510k NumberK864519
Device Name:PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
ClassificationSystem, Image Processing, Radiological
Applicant PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
ContactSayigh, Phd
CorrespondentSayigh, Phd
PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-17
Decision Date1987-02-13

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