Radiology · 510(k) · 2021
Cydar EV (Series B) and Cydar EV Maps
Cydar Ltd.. Cleared by FDA on 3 December 2021 under submission K212442, product code OWB (interventional fluoroscopic x-ray system). What FDA's record says, in FDA's words.
Device record · K212442
- Device. Cydar EV (Series B) and Cydar EV MapsDEVICE
- Company. Cydar Ltd. (GB)COMPANY
- Decision. 3 December 2021, 510(k), substantially equivalent (traditional review); received 4 August 2021DECISION
- Panel. RadiologyPANEL
- Product code. OWB, Interventional Fluoroscopic X-Ray SystemCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (13 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.
S05.1.5.2 Differences from Predicate Device S05.1.6 Predicate Device Comparison S05.1.7 Technological Characteristics S05.1.8 Performance Data S05.1.9 Benefit- Risk Conclusion S05.1 Section 5: 510(k) Summary S05.1.1 Submitter Details Business Name Cydar Ltd Address Bulbeck Mill Barrington Cambridgeshire CB22 7QY UK Contact person: • • • • • • • • • • • • Section 5: 510(k) Summary P age 1 of 10 K212442 Name Rob Hague Position CTO Phone number +44 1223 778 020 Email [email protected] US Agent: Contact Name Michael van der Woude Business Name Emergo Global Representation LLC Address 2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 United States Phone 512 327-9997 Fax 512 327-9998 Email [email protected] This summary was prepared on 2021-11-03. S05.1.2 The device is know as Cydar EV. It is an an evolution of a previous device of the same name, which is the subject of 510(k) K160088. To distinguish the two devices, the older device is referred to as Cydar EV Series A, and the device that is the subject of this application Cydar EV Series B. Unless otherwise stated, Cydar EV in this application refers to the subject device, Cydar EV Series B. Both devices are referred to as Cydar EV or Cydar EV Maps in all literature supplied to the user, with a version number to distinguish a specific release of the software. At the time Cydar EV Series B is placed on the market, the next version number will be assigned to the first release of that device. Type of 510(k) Submission […]
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.
- Mentionsnone of the tracked terms matched
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 2021. 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.