Soteria.AI
K212336Omega Medical Imaging, LLC · cleared 2021-11-17 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Soteria.AI system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria.AI interventional fluoroscopic X-ray system consists of: ... Built-in radiation safety controls-with the already FDA-cleared CA-100S / FluoroShield (K182834). The Omega Medical Imaging, LLC AI-100, Soteria.AI (SSXI) systems with FluoroShield / CA-100S device to provide an automated Region of interest that reduces exposure to the patient and operator.”
source quote (p.8)
“The Omega Medical Imaging, LLC AI-100, Soteria.AI (SSXI) systems with FluoroShield / CA-100S device to provide an automated Region of interest that reduces exposure to the patient and operator.”
source quote (p.8)
“privacy and security requirements, have been implemented.”
Validation studies (1)
Bench
sample size not stated
standards: IEC 62304 Medical device software – Software life cycle processes. FDA/CDRH recognition number 13-79., ISO 14971 Medical devices – Application of risk management to medical devices, IEC 60601-2-54 - Particular requirements for the basic safety and essential performance of X-ray Safety., Guidance for Industry and FDA Staff - Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337)., Guidance for Industry and FDA Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]”, July 28, 2014 (document number 1766)., 21 CFR 1020.30, 21 CFR 1020.31, and 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, and EN ISO 14971., UL 60601-1 and CAN/USA C22.2 No.601.1-M90., 21 CFR § 820 and ISO 13485 Standards., 21 CFR § 1020
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242488 (decision 2025-01-06) from Omega Medical Imaging, LLC for a matching device line ("Soteria E-View") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242488
- 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).