Duns Number:218286403
Device Description: The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The 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.
Catalog Number
-
Brand Name
Cydar EV
Version/Model Number
EV-2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160088
Product Code
OWB
Product Code Name
Interventional Fluoroscopic X-Ray System
Public Device Record Key
e4949acc-e803-4486-95c1-56173fa4243e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |