CT BIOPSYVIEW

System, X-ray, Tomography, Computed

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Ct Biopsyview.

Pre-market Notification Details

Device IDK983140
510k NumberK983140
Device Name:CT BIOPSYVIEW
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton,  CT  06484 -0197
ContactPeter Altman
CorrespondentPeter Altman
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton,  CT  06484 -0197
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-08
Decision Date1998-11-04
Summary:summary

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