CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

K191713

Omega Medical Imaging, LLC · cleared 2019-10-04 · product code JAA · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The-CA-100S/ FluoroShield™™ system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor (See Figure 1) . A dedicated computing device receives and analyzes the processed images from the REU. From these images, the ARP calculates the ROI settings that provide the most useful image to the physician or operator. Segmentation model: updated model based on trained images from the 2020 system.”
AlgorithmSegmentation model based on trained images, motion detection module, and tracking with prior probability.
source quote (p.12)
“Segmentation model: updated model based on trained images from the 2020 system. Motion detection module and its incorporation in tracking: a module that computes motion detection between consecutive frames, based on which a motion map is generated to improve tracking of the ROI in combination with the segmentation map. Prior probability in tracking and updated parameters: to improve ROI tracking performance.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.17)
“Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. (Document issued on October 2, 2014)”

Validation studies (3)

Bench

sample size not stated

endpoints: comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the CA-100S integrated with the Varex 3030 FPD verses the Varex 2020 FPD

Bench

sample size not stated

endpoints: further demonstrate the reduction of Patient dose

Prospective clinical

n=100 patients

endpoints: To compare and measure radiation exposure to patients by using dose area product (DAP).; To compare and measure scatter radiation to endoscopy personnel measured using Landauer Luxel personal dosimetry badges.

standards: 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, EN 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-54, EN ISO 15223-1, EN ISO 14971, UL 60601-1, CAN/USA C22.2 No.601.1-M90, 21 CFR § 820, ISO 13485, IEC60601-1, 21 CFR § 1020, 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

9
recalls in product code, 24mo
31
MAUDE reports in code, 12mo
-5%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code JAA (SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku, initiated 2024-09-06): "X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95450

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K191713