SmartCT R1.0

Interventional Fluoroscopic X-ray System

Philips Medical Systems, Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems, Nederland B.v. with the FDA for Smartct R1.0.

Pre-market Notification Details

Device IDK201583
510k NumberK201583
Device Name:SmartCT R1.0
ClassificationInterventional Fluoroscopic X-ray System
Applicant Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
ContactMaria Silos Viu
CorrespondentMaria Silos Viu
Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
Product CodeOWB  
Subsequent Product CodeJAK
Subsequent Product CodeLLZ
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2021-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838085732 K201583 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.