Soteria E-View

K242488

Omega Medical Imaging, LLC · cleared 2025-01-06 · product code JAA · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.6)
“The Soteria E-View system is classified as an interventional fluoroscopic X-ray system.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Software verification testing of the functional and non-functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and the privacy and security requirements, have been implemented.”

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304 Medical device software – Software life cycle processes., ISO 14971 Medical devices – Application of risk management to medical devices, IEC 60601-2-54 - Particular requirements for basic safety and essential performance of X-ray Safety., IEC60601-2-43 - Particular requirements for the basic safety and essential performance of x-ray equipment for interventional procedures., 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, EN ISO 15223-1, EN ISO 14971, UL 60601-1, CAN/USA C22.2 No.601.1-M90, 21 CFR § 820, ISO 13485 Standards, 21 CFR § 1020, 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

Retrospective clinical

sample size not stated

standards: IEC 62304 Medical device software – Software life cycle processes., ISO 14971 Medical devices – Application of risk management to medical devices, IEC 60601-2-54 - Particular requirements for basic safety and essential performance of X-ray Safety., IEC60601-2-43 - Particular requirements for the basic safety and essential performance of x-ray equipment for interventional procedures., 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, EN ISO 15223-1, EN ISO 14971, UL 60601-1, CAN/USA C22.2 No.601.1-M90, 21 CFR § 820, ISO 13485 Standards, 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/K242488