Philips India Limited

Address:Plot no. B-79, MIDC, Phase-II, Chakan,Pune Maharashtra,IN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Interventional Fluoroscopic X-Ray System (OWB) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

StentBoost - 00884838103450 Catalog Number : 718160

Device Description : StentBoost Mobile is a software product intended to provide a high resolution vi StentBoost Mobile is a software product intended to provide a high resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.

Device Class : 2

Duns Number: 650958353

Premarket Exempt : No

Product Code : OWB, LLZ

Prescription Use : Yes

Device Count : 1

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