CYDAR LIMITED

Address:Bulbeck Mill, 14 Mill Lane,Cambridge Cambridgeshire,GB

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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)

Premarket Exempt

Clear

Cydar EV - 05060508110002 Catalog Number :

Device Description : The Cydar EV software produces automated 3D overlays for use in endovascular sur The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performanceCydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.Note: Federal law (US) restricts this device to sale by or on the order of a physician.

Device Class : 2

Duns Number: 218286403

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

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