KOSMOS
K193518EchoNous, Inc. · cleared 2020-03-26 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“KOSMOS consists of a tablet and probe, which connects to the tablet via a cable.”
source quote (p.7)
“DA Pickup Sensor and Processing: Audio microphone + digital signal processing”
Validation studies (1)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1:2005/(R)2012 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (limited set of test requirements), ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires (limited set of test requirements), ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests, IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3, IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)], ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices - Applications of risk management to medical devices
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) K233826 (decision 2024-08-29) from EchoNous, Inc. for a matching device line ("Kosmos") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233826
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K212100 (decision 2021-08-06) from EchoNous, Inc. for a matching device line ("Kosmos") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K212100
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254
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).