CARA System
K252500Cara Medical, Ltd. · cleared 2026-02-20 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Cara Atlas Navigator consists of both software and hardware components: 1) Fluoroscopy Splitter (F-Splitter) – This device splits the live fluoroscopy image for integration with the CARA System. 2) CARA Box – A standard workstation that receives live fluoroscopy images from the Fluoroscopy Splitter and enhances them by adding anatomical landmarks.”
source quote (p.4)
“The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters.”
source quote (p.15)
“cybersecurity controls were validated against NIST SP 800-53 and FDA guidance to confirm the air-gapped architecture.”
Validation studies (3)
Bench
sample size not stated
endpoints: CT-to-fluoroscopy registration accuracy; system latency; image fidelity
standards: IEC 62304, IEC 60601-1, IEC 60601-1-2
Standalone
n=2,139 images
endpoints: Optical Character Recognition (OCR) error rate; Anatomical Segmentation (Cardiac Chambers) Dice Similarity Coefficient and Average Surface Distance; Aortic Segmentation Dice Similarity Coefficient; Catheter & Lead Detection distal tip localization error
Retrospective clinical
n=403 patients
endpoints: association between the CARA-visualized Conduction System Axis (CSA) and post-procedural outcomes; pacing effectiveness relative to the CARA-visualized Left Bundle Branch (LBBP)
Reported performance (2 observations)
source quote (p.15)
“Mean DSC = 0.962”
source quote (p.15)
“The system demonstrated latency of ≤ 133 ms (95% upper bound)”
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-08): "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor," Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98071
- …and 1 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).