Radiology · 510(k) · 2016
Cydar EV
Cydar Ltd.. Cleared by FDA on 7 July 2016 under submission K160088, product code OWB (interventional fluoroscopic x-ray system). What FDA's record says, in FDA's words.
Device record · K160088
- Device. Cydar EVDEVICE
- Company. Cydar Ltd. (GB)COMPANY
- Decision. 7 July 2016, 510(k), substantially equivalent (traditional review); received 15 January 2016DECISION
- Panel. RadiologyPANEL
- Product code. OWB, Interventional Fluoroscopic X-Ray SystemCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy , from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement. VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions. Similar; indications for both devices emphasize image guidance for fluoroscopy-guided endovascular procedures Exhibit DI-B - 4 Manufacturer Cydar Ltd Philips Medical Systems Nederland B.V. Significant Differences Trade Name Cydar EV (Subject device) VesselNavigator (Predicate device) veins. Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs. Construction Software product Software product Identical Host computer Separate interventional tools […]
The product code's definition, from FDA's classification record. Interventional fluoroscopy
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, radiographs (X-ray)
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 50,680 reports filed against devices carrying product code OWB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002661
It was reported to Philips that the system was unable to start up properly.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002659
It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002662
It was reported to Philips that the system was unable to perform exposure.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD20 · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002664
It was reported to Philips that the system's propellor geometry movement was not available.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002665
It was reported to Philips that the system could not emit X-ray.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OWB, in Radiology, from Cydar Ltd., or cleared in 2016. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.