Cydar EV
K160088Cydar Ltd. · cleared 2016-07-07 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Cydar EV is a software only medical device.”
source quote (p.8)
“2D-3D registration is achieved by machine vision tracking of vertebral anatomy”
source quote (p.9)
“Similar; automatic response to patient motion allows registration to continuously occur with no additional questions raised for safety or efficacy”
source quote (p.10)
“information security”
Validation studies (2)
Bench
sample size not stated
endpoints: registration accuracy calculated from images of the vertebral anatomy; overlay alignment accuracy in the web browser display; information security; responsiveness of overlays to changes in the fluoroscopy imagery
standards: IEC 62304:2015 Medical device software – Software life cycle processes, IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices, ISO 14971:2007 Medical devices – Application of risk management to medical devices, NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011), Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005)
Prospective clinical
sample size not stated
endpoints: accuracy; robustness; usability; procedure time; radiation exposure; iodinated contrast volume
Reported performance (1 observation)
source quote (p.11)
“Primary endpoints were the accuracy, robustness, usability, procedure time, radiation exposure, and iodinated contrast volume”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K212442 (decision 2021-12-03) from Cydar Ltd. for a matching device line ("Cydar EV (Series B) and Cydar EV Maps") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K212442
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99079
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99041
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98244
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98096
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98108
- …and 2 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).