Soteria E-View
K242488Omega Medical Imaging, LLC · cleared 2025-01-06 · product code JAA · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of: The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side.”
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
endpoints: validate image performance; demonstrate substantial equivalence to the predicate device; conformance to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use
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, 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
endpoints: validate image performance; demonstrate substantial equivalence to the predicate device; conformance to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use
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, 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
- 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). 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).