IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

System, X-ray, Tomography, Computed

IMATRON, INC.

The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Imatron Ultra Access Workstation With Cardiac Software Extensions.

Pre-market Notification Details

Device IDK972903
510k NumberK972903
Device Name:IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
ClassificationSystem, X-ray, Tomography, Computed
Applicant IMATRON, INC. 389 OYSTER POINT BLVD. South San Francisco,  CA  94080
ContactJ.a. Coduto
CorrespondentJ.a. Coduto
IMATRON, INC. 389 OYSTER POINT BLVD. South San Francisco,  CA  94080
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-06
Decision Date1997-11-04
Summary:summary

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